3 Summary of statements and recommendations
Compared with traditional sedation, propofol-based sedation presents similar rates
of adverse effects, provides higher postprocedure patient satisfaction for most endoscopic
procedures, decreases time to sedation, and decreases recovery time (and may therefore
decrease discharge time compared with traditional sedation). Propofol-based sedation
may also increase the quality of endoscopic examination. There are no cost-effectiveness
data directly comparing specifically NAAP with traditional sedation or monitored anesthesia
care for gastrointestinal endoscopy. (Evidence level 1+.)
Specific knowledge and skills are necessary for endoscopists and nursing staff using
NAAP to ensure patient comfort and safety; none of the NAAP reports published to date
used self-training to achieve competency in this technique. NAAP performed by endoscopists
and endoscopy nurses should not take place without appropriate training, and self-training
in NAAP is strongly discouraged. (Evidence level 2++, Recommendation grade A.)
Digestive endoscopists and registered nurses are adequate candidates for NAAP training
courses. Previous experience in intensive care medicine is desirable for the physician
who is responsible for NAAP. We recommend that training courses for NAAP include a
theoretical and a practical part, each part being followed by an examination to document
successful training. NAAP training courses should teach techniques of basic life support
(BLS) to all participants and advanced cardiac life support (ACLS) to caregivers who
will practice in locations where an ACLS provider is not immediately available. (Evidence
level 4, Recommendation grade D.)
Simulator training using a full-scale patient simulator as an adjunct to practical
NAAP courses allows improvement of trainees’ skill. We recommend the use of such simulators.
(Evidence Level 2–, Recommendation grade D.)
The first human cases of NAAP performed by a caregiver require particular attention
because complications are more frequent during this period. We recommend that the
first human cases of NAAP performed by an individual be supervised by an anesthesiologist
or another person with previous experience of > 300 NAAP cases (Evidence level 2–,
Recommendation grade D). There was dissension in the audience, with some participants
recommending preceptorship during the first cases of NAAP without defining ”first
cases”, and others preferring to state a number of cases (evidence only available
for n = 30).
Higher categories of the American Society of Anesthesiology (ASA) physical status
classification system and some endoscopic procedures are associated with a higher
incidence of complications after endoscopy. Higher Mallampati’s classes are associated
with more difficult airway management. We recommend that these risk factors are assessed
before each NAAP procedure by reviewing patient past medical history, performing a
focused physical examination, and assessing type and anticipated complexity of the
endoscopic procedure. (Evidence level 2+, Recommendation grade C.)
In the presence of patient-related risk factors for complications, the primary involvement
of an anesthesiologist during endoscopy is suggested. These factors include ASA category
≥ 3, a Mallampati’s class of 3 or other conditions at risk for airway obstruction
(e. g. pharyngolaryngeal tumors), patients who chronically receive significant amounts
of pain medications or in cases of anticipated long-lasting procedure. (Evidence level
4, Recommendation grade D.)
In the vast majority of NAAP studies, propofol was administered by a person who had
patient sedation as his/her sole task (Evidence level 1++). It is recommended that
patients be continuously monitored by a person dedicated to NAAP (Recommendation grade
A).
There is no evidence that quick availability of a life support team is required for
propofol administration. We do not recommend compulsory availability of a life support
team if propofol is administered in the presence of a person trained in ACLS. (Evidence
level 2+; Recommendation grade C.)
Intravenous access is required for sedation in gastrointestinal endoscopy and should
be maintained using a catheter, not a winged steel needle, until full patient recovery
(Evidence level 4, Recommendation grade D.)
Continuous supplemental oxygen is indicated during NAAP for endoscopy. (Evidence level
1+, Recommendation grade B.)
Patient monitoring is recommended in all patients using continuous pulse oximetry
and automated noninvasive blood pressure measurement (at baseline and then at 3 – 5-minute
intervals) during both NAAP and the recovery period; continuous electrocardiography
is recommended in selected patients with a history of cardiac and/or pulmonary disease.
Baseline, minimum and maximum heart rate/blood pressure, as well as baseline and minimum
oxygen blood saturation should be recorded. (Evidence level 2++, Recommendation grade
B.)
Visual assessment of respiratory activity during anticipated long endoscopy procedures
is not a reliable method for detecting apnea. During NAAP, capnographic monitoring
of respiratory activity may reduce episodes of hypoxemia during long endoscopic procedures
or when visual assessment of patient breathing is impaired, but no clinical impact
has been demonstrated. Therefore, capnography cannot be recommended as standard. (Evidence
level 1+, Recommendation grade B.)
Electroencephalogram (EEG)-based monitoring may be used during NAAP to target a sedation
level; it may help to reduce propofol consumption during complex endoscopic procedures
with targeted deep sedation. No clinical impact of EEG-based monitoring has been demonstrated
(Evidence level 1+), and no specific recommendation is made due to the paucity of
data.
Simple endoscopic procedures can be performed with moderate sedation, maintaining
a high degree of patient satisfaction. Prolonged or complex procedures (e. g. endoscopic
ultrasonography [EUS] and endoscopic retrograde cholangiopancreatography [ERCP]) are
frequently performed under deep sedation. (Evidence level 1++, Recommendation grade
A.)
Combining propofol with an additional drug (benzodiazepine/opioid/ketamine) allows
the dose of propofol administered to be decreased without reproducible effect on recovery
time; there is no clear evidence that combining propofol with another drug leads to
a decrease in adverse effects (Evidence level 1+). No recommendation is made about
combination of propofol with other drugs.
Intermittent bolus administration of propofol is the current standard administration
technique for NAAP. Data about propofol administration using perfusor systems during
endoscopy are accumulating and show that these systems are as effective and safe as
the standard technique. Patient-controlled sedation (PCS) is a valid administration
technique but it is not applicable in a significant minority of patients. (Evidence
level 1+.)
Listening to patient-selected music during colonoscopy allows the dose of propofol
administered to be decreased; we recommend this for colonoscopy. (Evidence level 1–,
Recommendation grade B.)
The role of pharyngeal anesthesia during propofol sedation for upper digestive endoscopy
has not been assessed. No recommendation is made.
Variable stiffness colonoscopes allow the dose of propofol administered to be decreased
during colonoscopy with no demonstrated clinical impact (Evidence level 1+). A single
endoscope manufacturer currently offers such models and no recommendation is made.
Postendoscopy pain is lower when air is replaced by CO2 for gut distension during long endoscopy procedures but there are no data on the
doses of propofol administered (Evidence level 1+). No recommendation is made.
Propofol is contraindicated in patients with a known allergy to soy protein. Pain
at the injection site is frequent and can be prevented by lidocaine (Evidence level
1++). Hypoxemia and hypotension are the most frequent adverse effects of propofol
and develop during NAAP in 5 % – 10 % of patients. Measures to be taken in case of
complications should be established in a check-list that is updated and tested at
regular intervals. If a patient proves difficult to sedate adequately for the examination
purpose, endoscopy termination and referral to an anesthesiologist should be considered
(Evidence level 4, Recommendation grade D).
A small minority of sedation-related adverse effects occur after, as opposed to during,
the procedure. We recommend patient observation until discharge by a person who is
aware of the adverse effects of the drugs administered. (Evidence level 2+, Recommendation
grade C.)
Minimum discharge criteria are useful for discharging patients after sedation for
digestive endoscopy. We recommend using a standardized discharge scoring form. (Evidence
level 2+, Recommendation grade C.)
Minimum discharge criteria should be fulfilled before discharging a patient. However,
psychomotor functions remain significantly impaired when standard discharge criteria
are met. Upon discharge, patients should be accompanied by a responsible person and
refrain from driving, operating heavy machinery or engaging in legally binding decisions
for at least 12 hours if sedation with propofol alone was administered (24 hours in
cases of a combined regimen). Advice should be provided verbally and in written form,
including a 24-hour contact phone number. (Evidence level 1+, Recommendation grade
A.)
Documentation should be maintained throughout all phases of patient management, including:
-
vital signs assessed at regular intervals (oxygen saturation, heart rate, and blood
pressure)
-
drugs (name, dosage), IV fluids (type, quantity), and oxygen (flow rate) administered
-
sedation-associated complications and their management
-
fulfillment of discharge criteria.
A minority of the audience thought that it should be recommended to record, in addition
to this, the level of consciousness at regular intervals. Maintaining documentation
in an electronic database may help to monitor quality and will provide a record in
the event of medicolegal investigation. (Evidence level 4, Recommendation grade D.)
The endoscopist bears the ultimate medicolegal responsibility to ensure proper personal
training of the endoscopy staff involved in NAAP. (Evidence level 4.)
Informed consent for NAAP should be obtained from the patient or his/her legal representative
according to domestic laws and regulations in a way similar to that of other endoscopy
procedures. It is generally obtained during a face-to-face discussion between a physician
familiar with the procedure and the patient, with information given in lay language
to the patient and the opportunity for him/her to ask questions prior to the procedure.
The informed consent regarding sedation issues may be incorporated into the main body
of the endoscopy consent form. The procedure of informed consent should be documented.
(Evidence level 4, Recommendation grade D.)
6 Practice of NAAP
6.1 Pre-procedure patient selection
Higher categories of the ASA physical status classification system and some endoscopic
procedures are associated with a higher incidence of complications after endoscopy.
Higher Mallampati’s classes are associated with more difficult airway management.
We recommend that these risk factors are assessed before each NAAP procedure by reviewing
patient past medical history, performing a focused physical examination, and assessing
type and anticipated complexity of the endoscopic procedure. (Evidence level 2+, Recommendation
grade C.)
Adequate patient selection for NAAP is important because a significant proportion
of complications observed after endoscopy are related to sedation and some of these
may be preventable [30]
[31]
[32]. Impaired physical status, procedure type, older age, and possibly obesity are risk
factors for the development of cardiopulmonary complications and mortality [30]
[32]
[33]. These factors should be assessed together with other useful elements (e. g. risk
factors for sleep apnea, abnormal head and neck features, chronic obstructive pulmonary
disease of stage 3 – 4, cardiac failure of stage 3 – 4, history of bronchoaspiration,
trouble with previous anesthesia or sedation, allergies, current medications, tobacco,
alcohol, and drug consumption) using a combination of standardized questionnaires
and nurse-based or physician-based assessment [34]. After physical examination including vital signs, heart and lung auscultation,
as well as throat examination, the patient is classified according to the ASA physical
status scale and Mallampati’s class [35]
[36].
In the presence of patient-related risk factors for complications, the primary involvement
of an anesthesiologist during endoscopy is suggested. These factors include ASA category
≥ 3, a Mallampati’s class of 3 or other conditions at risk for airway obstruction
(e. g. pharyngolaryngeal tumors), patients who chronically receive significant amounts
of pain medications or in cases of anticipated long-lasting procedure. (Evidence level
4, Recommendation grade D.)
The presence of some patient-related risk factors may trigger the consideration of
the primary involvement of an anesthesiologist during endoscopy [37]. Such factors are, for example: a history of stridor, snoring or sleep apnea; patients
with dysmorphic facial features (e. g. Pierre Robin syndrome, trisomy 21) or oral
abnormalities such as small opening (< 3 cm in an adult), high arched palate, macroglossia,
tonsilar hypertrophy, or a nonvisible uvula; patients with neck abnormalities, such
as obesity involving the neck and facial structures, short neck, limited neck extension,
neck mass, cervical spine disease or trauma, tracheal deviation, or advanced rheumatoid
arthritis; patients with jaw abnormalities, such as micrognathia, retrognathia, trismus,
or significant malocclusion; patients receiving significant amounts of pain medication
chronically or who for other reasons may be tolerant to agents used during sedation
and analgesia.
6.2 Performance of sedation
6.2.1 Personnel
In the vast majority of NAAP studies, propofol was administered by a person who had
patient sedation as his/her sole task (Evidence level 1++). It is recommended that
patients be continuously monitored by a person dedicated to NAAP (Recommendation grade
A).
Recent guidelines from the USA and Germany recommend that NAAP be performed by a person
who has NAAP as their sole task [16]
[17]. These recommendations are mostly based on expert opinions and they have recently
been challenged by reports suggesting that propofol administration in the presence
of the endoscopist and a single nurse is safe [29]
[38]
[39]. These reports included > 28 000 endoscopic procedures (mostly EGD and colonoscopy,
500 upper digestive EUS); no severe complications were reported except for requirement
for bag mask ventilation in six patients (0.02 %). However, blood pressure was not
monitored in a majority of these patients, and it is therefore unclear how often patients
might have presented critical hypotension.
There is no evidence that quick availability of a life support team is required for
propofol administration. We do not recommend compulsory availability of a life support
team if propofol is administered in the presence of a person trained in ACLS. (Evidence
level 2+; Recommendation grade C.)
6.2.2 Patient preparation and monitoring
Intravenous access is required for sedation in gastrointestinal endoscopy and should
be maintained using a catheter, not a winged steel needle until full patient recovery.
(Evidence level 4, Recommendation grade D.)
Permanent intravenous access is required for most protocols of NAAP (EGD after a single
bolus injection of propofol has been reported) [40]; Teflon cannulas are as easy to insert as winged steel needles and provide more
reliable intravenous access [41].
Continuous supplemental oxygen is indicated during NAAP for endoscopy. (Evidence level
1+, Recommendation grade B.)
Administration of oxygen is widely recommended because RCTs have shown that oxygen
desaturation is frequent during endoscopy if the patient breathes room air, and that
this may be prevented by supplemental oxygen administration during endoscopy under
traditional sedation [42]
[43]
[44]
[45]
[46]
[47]
[48]
[49]
[50]. However, the potential benefit of routine prophylactic oxygen supplementation in
terms of decreased cardiopulmonary complications is unclear [51].
Patient monitoring is recommended in all patients using continuous pulse oximetry
and automated noninvasive blood pressure measurement (at baseline and then at 3 – 5-minute
intervals) during both NAAP and the recovery period; continuous electrocardiography
is recommended in selected patients with a history of cardiac and/or pulmonary disease.
Baseline, minimum and maximum heart rate/blood pressure, as well as baseline and minimum
oxygen blood saturation should be recorded. (Evidence level 2++, Recommendation grade
B.)
Most studies that have established the safety of NAAP have used patient monitoring
as stated above [5]. Clinical utility of these measures has not been demonstrated but oximeters, electrocardiographs,
and devices that automatically monitor blood pressure at regular intervals are widely
available, relatively reliable, cheap, and easy to use. For example, pulse oximetry
was found to be used during colonoscopy in 77 % of > 6000 patients investigated in
11 European countries between 2000 and 2002 and in 97 % of all gastroscopies and colonoscopies
as shown in a recent nationwide survey in Germany [7]
[52]. For NAAP, such monitoring has become a de facto standard.
-
The utility of blood pressure monitoring during NAAP has not been studied but it is
intuitively important to monitor because a decrease in blood pressure is one of the
most frequent side effects of propofol, and it may require intervention.
-
The utility of continuous electrocardiographic monitoring during NAAP has not been
studied.
-
Pulse oximetry is a noninvasive technique that allows SpO2 measurement, i. e. the percentage of hemoglobin binding sites in the bloodstream
occupied by oxygen. It provides an early warning of hypoxemia but it is not an early
indicator of decreased ventilation.
Visual assessment of respiratory activity during anticipated long endoscopy procedures
is not a reliable method of detecting apnea. During NAAP, capnographic monitoring
of respiratory activity may reduce episodes of hypoxemia during long endoscopic procedures
or when visual assessment of patient breathing is impaired, but no clinical impact
has been demonstrated. Therefore, capnography cannot be recommended as standard. (Evidence
level 1+, Recommendation grade B.)
Most episodes of apnea and disordered respiration remain undetected by visual assessment
of respiratory activity during anticipated long endoscopy procedures [53]. Two RCTs with a total of 426 patients have compared rapid vs. delayed signaling
of respiratory abnormalities, as detected by capnography monitor, to the endoscopy
team during sedation for endoscopy in adults and children [54]
[55]. Hypoxemia developed significantly more frequently in the capnography-blinded group
vs. capnography-aware group in both studies, but no difference in clinically relevant
outcomes (e. g. complication rate) was found in either study. Furthermore, in one
of these RCTs, capnography erroneously displayed a flat line for at least 50 seconds
in 13 % of patients [54]. Clinical usefulness of capnography should be assessed in patients considered to
be at high-risk for morbidity from hypoxemia (e. g. severe cardiovascular disease).
EEG-based monitoring may be used during NAAP to target a sedation level; it may help
to reduce propofol consumption during complex endoscopic procedures with targeted
deep sedation. No clinical impact of EEG-based monitoring has been demonstrated (Evidence
level 1+), and no specific recommendation is made due to the paucity of data.
The bispectral index (BIS) is a variable derived from the EEG that allows the quantification
of the hypnotic effects of anesthetic drugs on the central nervous system. Four RCTs
assessing the usefulness of BIS during propofol sedation for endoscopy have been identified
[56]
[57]
[58]
[59]. In these RCTs, the administration of propofol was controlled based on BIS vs. clinical
parameters. Two RCTs that included patients with colonoscopy or gastric endoscopic
submucosal dissection found no difference between randomization groups, in particular
with regard to propofol consumption or recovery time (one study found better patient
and [unblinded] endoscopist satisfaction with BIS) [56]
[57]. The two other RCTs included patients subjected to ERCP; both RCTs found that the
propofol dose was significantly lower and the recovery time shorter in patients randomized
to BIS compared with those randomized to clinical parameters for the monitoring of
propofol administration [58]
[59]. In one of these RCTs [58], propofol was administered by an anesthesiologist; no side effect was attributed
to the use of BIS.
6.2.3 Level of sedation
Simple endoscopic procedures can be performed with moderate sedation, maintaining
a high degree of patient satisfaction. Prolonged or complex procedures (e. g. EUS
and ERCP) are frequently performed under deep sedation. (Evidence level 1++, Recommendation
grade A.)
The level of sedation can be assessed using different scales; an example is given
in [Table 4] [60]
[61]
[62].
Table 4 Stages of sedation modified according to the American Society of Anesthesiologists
[60].
|
Minimal
(anxiolysis) |
Moderate |
Deep |
Anesthesia |
| Reaction being addressed |
Patient reaction is adequate to verbal commands |
Somnolence, reaction to louder commands, if needed with additional tactile stimulation
|
Somnolence, hard to wake, targeted reaction to repeated tactile stimulation and pain
stimulus |
Patient cannot be woken, not even in response to pain stimuli |
| Spontaneous breathing |
Not influenced |
Adequate |
Respiratory function mildly restricted |
Inadequate, orotracheal intubation or larynx mask necessary |
For EGD and colonoscopy, moderate sedation provides a high level of physician and
patient satisfaction and a low risk of serious adverse events with all currently available
agents [3]. For more complex procedures such as EUS and ERCP, a deep sedation level has been
targeted in a majority of studies, mostly to avoid involuntary patient movements [9]
[10]
[11]
[39]
[63]
[64]
[65].
6.2.4 Protocols of propofol-based sedation
6.2.4.1 Propofol alone or combined with other drugs
Combining propofol with an additional drug (benzodiazepine/opioid/ketamine) allows
the dose of propofol administered to be decreased without reproducible effect on recovery
time; there is no clear evidence that combining propofol with another drug leads to
a decrease in adverse effects (Evidence level 1+). No recommendation is made about
combination of propofol with other drugs.
Seven RCTs compared sedation with propofol administered alone vs. combined with midazolam
and/or fentanyl or with a cocktail of various drugs ([Table 5]).
Table 5 Main outcomes in randomized controlled trials comparing propofol used in monotherapy
or in combination with other sedative drugs.
| Study |
N |
Drugs combined |
Procedure |
Mean propofol dose |
Mean recovery time, minutes |
Complications |
|
|
|
|
Monotherapy |
Combined regimen |
Monotherapy |
Combined regimen |
Monotherapy |
Combined regimen |
| Disma et al. 2005 [66]
|
240 |
M or F |
EGD |
3.5 mg/kg |
3.2 mg/kg |
51.5 |
54 |
19 %* |
5 – 6 % |
| Paspatis et al. 2006 [67]
|
54 |
M |
EGD |
2.9 mg/kg** |
1.8 mg/kg |
7.7** |
25.9 |
O2 < 92 %: 15.3 %
ΔMBP > 10 mmHg: 0 |
21.4 %
3.5 % |
| VanNatta & Rex 2006 [69]
|
200 |
M, or F, or M+F |
Colonoscopy |
215 mg** |
82.5 – 140 mg |
18.1** |
13.9 – 14.7 |
ND |
ND |
| Fanti et al. 2007 [70]
|
270 |
M |
Upper EUS |
364 mg |
394 mg |
39 |
38 |
0 |
0 |
| Ong et al. 2007 [65]
|
199 |
M+P+K |
ERCP |
192 mg*** |
131 mg |
NA |
NA |
4.8 %* |
15.8 % |
| Paspatis et al. 2008 [64]
|
91 |
M |
ERCP |
512 mg*** |
331 mg |
30.6** |
35.5 |
O2 < 90 %: 24.4 %*
SBP < 90 mmHg: 4.4 % |
6.5 %
6.5 % |
| Padmanabhan et al. 2009 [68]
|
200 |
M, or F, or M+F |
Colonoscopy |
285 mg*** |
200 mg |
66 |
64 |
ND |
ND |
EGD, esophagogastroduodenoscopy; ERCP, endoscopic retrograde cholangio-pancreatography;
EUS, endoscopic ultrasonography.
F, fentanyl; K, ketamine; M, midazolam; P, pentazocine.
NA, not available; ND, no difference between groups without more precision in the
original article; ΔMBP, change in mean arterial blood pressure; SBP, systolic blood
pressure.
*P < 0.05; **P < 0.01; ***P < 0.001. |
Different endoscopic procedures were analyzed and two RCTs were performed in children
[66]
[67]. Most trials found that the doses of propofol were lower with combined vs. monotherapy
regimens but results in terms of recovery times were contradictory. Complications
were significantly less frequent with combined regimens in two RCTs that used midazolam
[64]
[66], and were more frequent when propofol was combined with a “cocktail” including midazolam,
ketamine, and pentazocine [65]. Endoscopy was rated as easier with combined regimens vs. propofol monotherapy in
two RCTS [66]
[68]. Patient satisfaction was similar with propofol monotherapy vs. combined regimens,
except for more late pain recall with a combined regimen in one trial [69].
6.2.4.2 Propofol administration techniques
Intermittent bolus administration of propofol is the current standard administration
technique for NAAP. Data about propofol administration using perfusor systems during
endoscopy are accumulating and show that these systems are as effective and safe as
the standard technique. PCS is a valid administration technique but it is not applicable
in a significant minority of patients. (Evidence level 1+.)
Propofol may be administered intravenously as repeated bolus injections, continuous
infusion or a mixture of both techniques. Most trials dealing with propofol for digestive
endoscopy have used repeat bolus injections by a caregiver or continuous infusion
at a fixed rate; other techniques include PCS, target-controlled infusion (TCI) and,
mostly for clinical research, “computer-assisted personalized sedation” (CAPS).
Standard techniques
An initial bolus of propofol (dose adapted to patient weight, age or comorbidity)
is administered intravenously, followed by repeated boli according to patient condition
or by a continuous propofol infusion (infusion rate is chosen according to the desired
sedation depth and the patient risk profile, with additional boli administered as
needed). These are the best documented and the most often used administration techniques
for propofol.
Patient-controlled sedation
In PCS, a computerized pump is programed to deliver intravenously a predetermined
amount of sedative and/or opioid when the patient presses a button. This technique
has mostly been used for colonoscopy. A Cochrane meta-analysis of RCTs comparing propofol
with traditional sedation for colonoscopy has shown that, with PCS, complication rates
were similar, pain control was inferior (even in studies that used propofol combined
with an analgesic) but patient satisfaction was higher than with traditional agents
[13]. This discordance between pain and patient satisfaction likely reflects the fact
that patients appreciate deciding about their appropriate sedation level.
Three RCTs have randomized patients scheduled to colonoscopy for the administration
of propofol (alone or in combined regimen) via PCS vs. via continuous infusion or
repeat bolus administrations by a trained nurse. Of note, 34 % of the 453 patients
eligible for randomization in these trials refused inclusion. In terms of patient
safety, no clinically significant difference between the administration techniques
was detected. The doses of propofol were similar between randomization groups in two
RCTs and lower in the PCS group in one study [71]. Patient satisfaction was significantly higher with PCS in one of three trials [72]; willingness to repeat the examination was evaluated in two trials and it was significantly
higher with the PCS in one of them [71]. The advantage of PCS in terms of cost (no dedicated nurse) may be offset by the
cost of different propofol formulations used for PCS [73].
Target-controlled infusion and computer-assisted personalized sedation
With these techniques, the infusion rate is adjusted by a computer, either in an “open-loop”
system based on fixed parameters (e. g. body weight) or in a “closed-loop” system
that uses feedback from a real-time measure of drug effect (e. g. patient reaction
to tactile stimuli or BIS) [74]
[75]. These systems are called TCI and CAPS, respectively. Too few data have been reported
in the endoscopy field to draw conclusions with these systems but, for TCI in adult
surgical patients, no clinically significant differences were demonstrated in terms
of quality of anesthesia or adverse events with TCI vs. manually controlled infusion
of propofol (Cochrane meta-analysis) [76].
6.2.5 Non-pharmacological measures available to reduce doses of propofol
6.2.5.1 Listening to music
Listening to patient-selected music during colonoscopy allows the dose of propofol
administered to be decreased; we recommend this for colonoscopy. (Evidence level 1–,
Recommendation grade B.)
Three meta-analyses have reported the effect of listening to music on sedative drug
consumption during colonoscopy [77]
[78]
[79]. Differences in the amounts of drugs used between the intervention and control groups
were not statistically significant in two meta-analyses [77]
[78], and they were marginally significant in the third one due to the inclusion of one
additional RCT that used propofol for sedation (midazolam was used in the RCTs included
in the two other meta-analyses) [79]. In the additional RCT [80], propofol mixed with alfentanil was self-administered via PCS in the intervention
and control groups; patients with headphones and a choice of different music types
(intervention group) self-injected less drug than control patients. One meta-analysis
also included patients undergoing EGD and sigmoidoscopy; listening to music may also
be beneficial for these interventions [78].
6.2.5.2 Pharyngeal anesthesia
The role of pharyngeal anesthesia during propofol sedation for upper digestive endoscopy
has not been assessed. No recommendation is made.
Pharyngeal anesthesia decreases patient discomfort during upper digestive endoscopy
under traditional sedation but it has not been investigated for endoscopy under propofol
sedation [81]. Impact on consumption of traditional agents and on recovery was not reported in
available trials.
6.2.5.3 Special endoscopes
Variable stiffness colonoscopes allow the dose of propofol administered to be decreased
during colonoscopy with no demonstrated clinical impact (Evidence level 1+). A single
endoscope manufacturer currently offers such models and no recommendation is made.
A meta-analysis of seven RCTs showed that sedative drugs were used in significantly
lower amounts and that cecal intubation rate was higher when colonoscopy was performed
using a variable stiffness colonoscope vs. a standard colonoscope [82]. One of these seven RCTs used propofol for sedation; it found that patients self-administered
(via PCS) significantly lower amounts of propofol when a variable stiffness colonoscope
was used but no impact on sedation-related complications (hypotension, oxygen desaturation)
or recovery time was found [83].
6.2.5.4 Use of CO2 as air replacement for gut distension
Postendoscopy pain is lower when air is replaced by CO2 for gut distension during long endoscopy procedures but there are no data on the
doses of propofol administered (Evidence level 1+). No recommendation is made.
Two RCTs compared CO2 vs. air for gut distension during ERCP and colonoscopy performed under propofol sedation
[84]
[85]. Impact on the dose of propofol administered was not reported and recovery time
was similar with both gases in one study [84]. Postendoscopy pain was significantly lower with CO2 vs. air.
6.2.6 Precautions and management of complications
Propofol is contraindicated in patients with a known allergy to soy protein. Pain
at the injection site is frequent and can be prevented by lidocaine (Evidence level
1++). Hypoxemia and hypotension are the most frequent adverse effects of propofol
and develop during NAAP in 5 % – 10 % of patients. Measures to be taken in case of
complications should be established in a check-list that is updated and tested at
regular intervals. If a patient proves difficult to sedate adequately for the examination
purpose, endoscopy termination and referral to an anesthesiologist should be considered
(Evidence level 4, Recommendation grade D).
Strict aseptic conditions, including the use of separate propofol vials for each patient,
should be maintained during manipulation of propofol, as bacterial and viral (hepatitis
C) contaminations have been reported [86]
[87]. Recommendations about allergies to some components (e. g. eggs, peanuts, sulfites)
vary depending on the propofol formulation and this should be checked according to
recommendations by the manufacturer of the formulation used. A so-called “propofol
infusion syndrome” (with rhabdomyolysis) has also been described (initially after
long-term, high-dose, administration of propofol in intensive care units but more
recently with short administration of lower doses) [88]. Propofol is contraindicated in patients with a known allergy to soy protein. Propofol
may cause pain at the injection site; this may be prevented in 60 % of patients by
intravenous administration of lidocaine (0.5 mg/kg) with a rubber tourniquet on the
forearm [89].
Hypoxemia and hypotension, the most frequent adverse effects of propofol, are usually
defined as hemoglobin oxygen saturation < 90 % and systolic blood pressure < 90 mmHg,
respectively. Their incidence during propofol-based sedation was, in a meta-analysis,
11 % (95 % confidence interval [CI], 7 % – 16 %) and 5 % (95 % CI 2 % – 10 %), respectively
[3].
Measures that should be taken when hypoxemia develops include stopping the infusion
of sedative drugs, increasing oxygen supply, maintaining the airway patent (by jaw-thrust
maneuver, suctioning, and mask ventilation). Flumazenil/naloxone may be administered
if benzodiazepines/opioids have been used. If the patient does not respond adequately
to these measures, endoscopy should be stopped. If hypoxemia does not reverse, emergency
call must be performed according to local protocols and ACLS must be initiated. In
cases of arterial hypotension, an electrolyte solution should be administered, possibly
associated with catecholamines. In cases of bradycardia, atropine should be administered
intravenously.
6.3 Post-sedation care
6.3.1 Surveillance during recovery
A small minority of sedation-related adverse effects occur after, as opposed to during,
the procedure. We recommend patient observation until discharge by a person who is
aware of the adverse effects of the drugs administered. (Evidence level 2+, Recommendation
grade C.)
A large prospective study showed that serious adverse effects may occur up to 30 minutes
after the administration of benzodiazepines and opioids for sedation, but postprocedure
adverse effects represented < 10 % of per-procedure adverse effects [90]. Serious postprocedure adverse effects are less frequent with propofol compared
with a combination of midazolam/meperidine [11]. During recovery, patients should be observed by a person who is aware of the side
effects of the drugs administered using monitoring equipment similar to that used
during the procedure. This person may perform minor interruptible tasks but should
not leave the room. Although it is possible to observe patients in the examination
room, we recommend a separate room for practical reasons.
6.3.2 Discharge
Minimum discharge criteria are useful for discharging patients after sedation for
digestive endoscopy. We recommend using a standardized discharge scoring form (e. g. [Table 6]
). (Evidence level 2+, Recommendation grade C.)
Table 6 Example of checklist for home discharge after digestive endoscopy under sedation.
| Stable vital signs for at least 1 hour |
| Alert and oriented to time, place, and person (infants and patients whose mental status
was initially abnormal should have returned to their baseline status) |
| No excessive pain, bleeding, or nausea |
| Ability to dress and walk with assistance |
| Discharged home with a responsible adult who will remain with the patient overnight
to report any postprocedure complications |
| Written and verbal instructions outlining diet, activity, medications, follow-up appointments,
and a phone number to be called in case of emergency |
| A contact person and circumstances that warrant seeking the assistance of a health
care professional clearly outlined |
| Tolerating oral fluids not mandatory, unless specified by physician (i. e. patient
is diabetic, frail, and/or elderly; not able to tolerate an extended period of NPO
status) |
| Adapted from Ead [94]. |
Various scoring systems devised for the assessment of postsurgical recovery have been
used after sedation for endoscopy, the most popular systems being the modified Aldrete
score (for early or phase I recovery) and the postanesthetic discharge scoring system
(PADSS, for intermediate or phase II recovery) [91]
[92]. Despite limitations of PADSS inherent to its focus on surgical procedures (e. g.
one of the five criteria in this system is “surgical bleeding”), it has been documented
to allow safe discharge after digestive endoscopy in a relatively small prospective
study [93]. A checklist ([Table 6]) is proposed to assess home-readiness of patients after digestive endoscopy under
sedation. At a minimum, criteria proposed by the ASA should be met [37]. Commonly used tests to evaluate psychomotor functions are coherent response to
questions, ability to stand on one foot, and ability to walk in a straight line for
5 m without instability.
Minimum discharge criteria should be fulfilled before discharging a patient. However,
psychomotor functions remain significantly impaired when standard discharge criteria
are met. Upon discharge, patients should be accompanied by a responsible person and
refrain from driving, operating heavy machinery or engaging in legally binding decisions
for at least 12 hours if sedation with propofol alone was administered (24 hours in
cases of combined regimen). Advice should be provided verbally and in written form,
including a 24-hour contact phone number. (Evidence level 1+, Recommendation grade
A.)
Psychomotor functions remain significantly impaired when standard discharge criteria
are met [95]. Therefore, patients should be informed in advance of precautions to be taken after
discharge; these instructions should be repeated at the time of discharge. Precautions
include the presence of an escort to ensure safe return home in cases of outpatient
procedures.
Psychomotor recovery is significantly more rapid with propofol vs. traditional sedation:
in two RCTs that compared propofol with midazolam/pethidine for EGD/colonoscopy, patients
who had received propofol had no impairment of psychomotor functions 2 hours after
sedation as measured by a driving simulator test, in contrast to those who had received
midazolam/pethidine [40]
[96]. However, both studies employed relatively low doses of propofol. In another study,
92 % of 400 patients who received low-dose propofol for EGD wanted to drive when leaving
the endoscopy unit, and all did so without incident [97]. Therefore, current recommendations from various professional associations to neither
drive nor use public transport without an accompanying person, nor operate heavy machinery
or engage in any legal decision making for 24 hours seem too strict if propofol is
used in low-dose monotherapy.
6.4 Procedure documentation and medicolegal issues
Documentation should be maintained throughout all phases of patient management, including:
-
vital signs assessed at regular intervals (oxygen saturation, heart rate, and blood
pressure)
-
drugs (name, dosage), IV fluids (type, quantity), and oxygen (flow rate) administered
-
sedation-associated complications and their management
-
fulfillment of discharge criteria.
A minority of the audience thought that it should be recommended to record, in addition
to this, the level of consciousness at regular intervals. Maintaining documentation
in an electronic database may help to monitor quality and will provide a record in
the event of medicolegal investigation. (Evidence level 4, Recommendation grade D.)
A structured procedural sedation record is part of a quality process and may help
to improve compliance with sedation guidelines [98].
The endoscopist bears the ultimate medicolegal responsibility to ensure proper personal
training of the endoscopy staff involved in NAAP. (Evidence level 4.)
Medicolegal issues are important when considering NAAP because (1) up to half of complications
after endoscopic procedures are related to sedation, and (2) in two surveys, a majority
of endoscopists cited “medicolegal issues” as the main reason for not embracing NAAP
[7]
[99]. The fact that the label accompanying propofol packages in many countries stipulates
that “propofol should be administered only by persons trained in the administration
of general anesthesia” means that, in some countries, during NAAP, propofol is used
“off-label”. Off-label use of drugs is common in medical practice and it has been
endorsed by various associations such as the Food and Drug Administration and the
American Medical Association [100]. However, departure from label recommendations may in some courts shift the burden
of proving that the method of use accords with recognized clinical practice to the
defendant.
Informed consent for NAAP should be obtained from the patient or his/her legal representative
according to domestic laws and regulations in a way similar to that of other endoscopy
procedures. It is generally obtained during a face-to-face discussion between a physician
familiar with the procedure and the patient, with information given in lay language
to the patient and the opportunity for him/her to ask questions prior to the procedure.
The informed consent regarding sedation issues may be incorporated into the main body
of the endoscopy consent form. The procedure of informed consent should be documented.
(Evidence level 4, Recommendation grade D.)
A significant proportion of complications after endoscopy are related to sedation
[30]
[31]. In a series of 59 ERCP procedures for which malpractice was alleged, Cotton showed
the importance of face-to-face communication between the endoscopist and the patient
[101]. Information pertaining to sedation should be provided, including pros and cons
of sedation with alternatives and the option for unsedated endoscopy, potential complications,
postprocedure risks related to driving, operating equipment where psychomotor functions
are essential, consuming alcohol and drugs, taking legally binding decisions, and
the risk of amnesia.
