EFFICACY OF SIMETHICONE AND N-ACETYLCYSTEINE COMBINATION PREMEDICATION PRIOR TO ESOPHAGOGASTRODUODENOSCOPY TO IMPROVE MUCOSAL VISIBILITY – A PROSPECTIVE DOUBLE BLINDED RANDOMIZED PLACEBO CONTROLLED TRIAL (CTRI/2017/09/009913)

Aims:

To detect whether the combination of Simethicone with N-Acetyl Cystiene as premedication before Upper GI endoscopy improves mucosal visualization?

Primary outcome: To find the effectiveness of Simethicone with N-AcetylCystiene combination for better mucosal visibility using Total Mucosal Visibility Score (TMVS)

Secondary outcome:

1. To estimate the total duration of the procedure time for each patient in various arms of the study groups

2. To estimate the number of lesions detected in each study group

Methods:

A total of 768 consecutive patients were recruited. Informed consent was taken. The study was registered with Clinical Trials Registry of India (CTRI). The patients were randomized into four groups using sealed envelopes and the endoscopist was blinded for it. Group

(A) N-Acetyl cysteine alone

(B) Simethicone alone

(C) Simethicone + N-Acetyl cysteine

(D) Placebo.

After randomization each patient was asked to drink 90 ml solution. Each 90 ml solution contain (15 ml Emulsion of Group A or B or C + 75 ml of water) and just plain water as placebo in group D. After 20 minutes of consuming the solution, Gastroscopy was done and multiple images were taken from esophagus, stomach and duodenum. Based on the various images obtained the TMVS, total duration of procedure and total number of lesions detected were calculated. SPSS software was used to analyze.

Results:

Tab. 1:

Results of the study

Objectives of the study	Group – A (N-Acetyl cysteine alone)	Group – B (Simethicone alone)	Group – C (Simethicone + N-Acetyl cysteine)	Group – D (Placebo)	“p” value
Total Mucosal Visibility Score	1.71	1.32	1.2	2.74	0.03
Total duration of the procedure (Mean)	5 Min 45 s	4 Min 50 s	4 Min 15 s	6 Min 15 s	0.021
Total number of lesions detected	48	56	72	32	0.042

Conclusions:

Premedication with simethicone and N-acetylcysteine markedly improves the mucosal visibility, detects more lesions and reduces the time taken during gastroscopy. This low-cost and well tolerated intervention may improve the detection of early neoplastic lesions which are still missed.