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

Gastrointest Endosc. 2004 Jan;59(1):22-7. doi: 10.1016/s0016-5107(03)02377-0.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Analgesia, Patient-Controlled*
  • Butylscopolammonium Bromide / therapeutic use*
  • Colon
  • Colonoscopy / adverse effects*
  • Double-Blind Method
  • Humans
  • Middle Aged
  • Muscarinic Antagonists / therapeutic use*
  • Pain Measurement
  • Prospective Studies
  • Severity of Illness Index
  • Spasm / etiology
  • Spasm / prevention & control*

Substances

  • Muscarinic Antagonists
  • Butylscopolammonium Bromide