Randomized, double-blinded, placebo-controlled trial of intravenously administered hyoscine N-butyl bromide in patients undergoing colonoscopy with patient-controlled sedation

Abstract

Background A prospective, double-blinded, placebo-controlled randomized trial was conducted to investigate the effect of the antispasmodic hyoscine N-butyl bromide (Buscopan) during colonoscopy. Methods A total of 120 patients undergoing colonoscopy were randomized to receive either 40 mg of hyoscine N-butyl bromide (n = 60) or normal saline solution (n = 60) intravenously as premedication. Colonoscopy was performed under patient-controlled sedation. Outcome measures included cecal intubation and total procedure time, demanded and administered doses of patient-controlled sedation, spasm score, pain score, endoscopist satisfaction score, patient willingness to repeat colonoscopy, and vital signs (blood pressure, pulse rate) during colonoscopy. Results Mean cecal intubation time in the hyoscine N-butyl bromide group was significantly longer than the control group (12.20 vs. 9.74 minutes; p = 0.04; but correction for multiple testing of data removed this significance). The use of hyoscine N-butyl bromide was associated with a significantly lower endoscopist mean satisfaction score (6.47 vs. 7.30; p = 0.04; but correction for multiple testing of data removed this significance), higher demanded and administered mean doses of patient-controlled sedation (respectively, 34.80 and 7.25 vs. 24.20 and 5.87; p = 0.045; p = 0.04, respectively; but correction for multiple testing of data removed these findings of significance), fewer patients willing to repeat colonoscopy (60% vs. 83.9%; p = 0.005), and more hemodynamic instability ( p<0.001) when compared with the control group. No significant difference was found in the total procedure time, spasm score, or pain score. Conclusions Premedication with intravenously administered hyoscine N-butyl bromide impedes colonoscope insertion and causes greater patient discomfort, as well as hemodynamic instability.