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DOI: 10.1055/s-0034-1393117
Capnographic monitoring of midazolam and propofol sedation during ERCP: a randomized controlled study (EndoBreath Study)
Publication History
submitted 11 April 2015
accepted after revision 13 July 2015
Publication Date:
28 September 2015 (online)
![](https://www.thieme-connect.de/media/endoscopy/201601/lookinside/thumbnails/12394_10-1055-s-0034-1393117-1.jpg)
Background and study aims: This was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxemia during midazolam and propofol sedation for endoscopic retrograde cholangiopancreatography (ERCP).
Methods: Patients (American Society of Anesthesiologists [ASA] I – IV) scheduled for ERCP under midazolam and propofol sedation were randomly assigned to a control arm with standard monitoring or an interventional arm with additional capnographic monitoring. In both arms detection of apnea prompted withholding of propofol administration, stimulation of the patient, insertion of a nasopharyngeal tube, or further measures. The primary study end point was incidence of hypoxemia (oxygen saturation [Sao 2] below 90 %); secondary end points included occurrences of severe hypoxemia (Sao 2 ≤ 85 %), bradycardia, and hypotension, and sedation quality (patient cooperation and satisfaction).
Results: 242 patients were enrolled at three German endoscopy centers. Intention-to-treat analysis revealed no significant reduction in hypoxemia incidence in the capnography arm compared with the standard arm (38.0 % vs. 44.4 %, P = 0.314). Apnea was more frequently detected in the capnography arm (64.5 % vs. 6.0 %, P < 0.001). There were no differences regarding rates of bradycardia and hypotension. Per-protocol analysis showed lower incidence of hypoxemia in the capnography arm compared with the standard arm (31.5 % vs. 44.8 %, P = 0.048). There was one death related to sedation in the standard arm. Sedation quality was similar in the two groups.
Conclusion: Intention-to-treat analysis showed hypoxemia incidence was not significantly lower in the additional capnography arm compared with standard monitoring. Additional capnographic monitoring of ventilatory activity resulted in improved detection of apnea.
ClinicalTrials.gov identifier: NCT01072474.
* These authors contributed equally to the study.
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References
- 1 McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc 2008; 67: 910-923
- 2 Gerstenberger PD. Capnography and patient safety for endoscopy. Clin Gastroenterol Hepatol 2010; 8: 423-425
- 3 Vargo JJ, Zuccaro Jr G, Dumot JA et al. Automated graphic assessment of respiratory activity is superior to pulse oximetry and visual assessment for the detection of early respiratory depression during therapeutic upper endoscopy. Gastrointest Endosc 2002; 55: 826-831
- 4 Burton JH, Harrah JD, Germann CA et al. Does end-tidal carbon dioxide monitoring detect respiratory events prior to current sedation monitoring practices?. Acad Emerg Med 2006; 13: 500-504
- 5 Deitch K, Miner J, Chudnofsky CR et al. Does end tidal CO2 monitoring during emergency department procedural sedation and analgesia with propofol decrease the incidence of hypoxic events? A randomized, controlled trial. Ann Emerg Med 2010; 55: 258-264
- 6 R Core Team. R: A language and environment for statistical computing. Vienna: R Foundation for Statistical Computing; 2014 http://www.R-project.org/
- 7 Riphaus A, Wehrmann T, Weber B et al. [S3-guidelines – sedation in gastrointestinal endoscopy]. Z Gastroenterol 2008; 46: 1298-1330 DOI: 10.1055/s-2008-1027850.
- 8 Bell GD. Preparation, premedication, and surveillance. Endoscopy 2004; 36: 23-31
- 9 Manifold CA, Davids N, Villers LC et al. Capnography for the nonintubated patient in the emergency setting. J Emerg Med 2013; 45: 626-632
- 10 Lichtenstein DR, Jagannath S, Baron TH et al. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc 2008; 68: 815-826
- 11 Dumonceau JM, Riphaus A, Aparicio JR et al. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy 2010; 42: 960-974
- 12 ASGE Technology Committee Gottlieb KT, Banerjee S, Barth BA. et al. Monitoring equipment for endoscopy. Gastrointest Endosc 2013; 77: 175-180
- 13 American Society for Gastrointestinal Endoscopy, American Gastroenterological Association, American College of Gastroenterology. MultiSociety Statement: Universal adoption of capnography for moderate sedation in adults undergoing upper endoscopy and colonoscopy has not been shown to improve patient safety or clinical outcomes and significantly increases costs for moderate sedation. http://www.asge.org/WorkArea/showcontent.aspx?id=14226 [Accessed: January 10, 2015]
- 14 Lightdale JR, Goldmann DA, Feldman HA et al. Microstream capnography improves patient monitoring during moderate sedation: a randomized, controlled trial. Pediatrics 2006; 117: e1170-e1178
- 15 Beitz A, Riphaus A, Meining A et al. Capnographic monitoring reduces the incidence of arterial oxygen desaturation and hypoxemia during propofol sedation for colonoscopy: a randomized, controlled study (ColoCap Study). Am J Gastroenterol 2012; 107: 1205-1212
- 16 Qadeer MA, Vargo JJ, Dumot JA et al. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology 2009; 136: 1568-1576
- 17 Rex DK, Deenadayalu VP, Eid E et al. Endoscopist-directed administration of propofol: a worldwide safety experience. Gastroenterology 2009; 137: 1229-1237
- 18 Behrens A, Labenz J, Schuler A et al. [How safe is sedation in gastrointestinal endoscopy? A multicentre analysis of 388,404 endoscopies and analysis of data from prospective registries of complications managed by members of the Working Group of Leading Hospital Gastroenterologists (ALGK)]. Z Gastroenterol 2013; 51: 432-436