OBJECTIVE: To determine the efficacy of scopolamine administered transdermally before laparoscopic cholecystectomy as a means of reducing postoperative nausea and vomiting. DESIGN: A randomized, double-blind, placebo-controlled study. SETTING: A tertiary-care, university-affiliated hospital. PATIENTS: A volunteer sample of 125 men and women between 20 and 60 years of age scheduled to undergoelective laparoscopic cholecystectomy. Expectant or nursing mothers were excluded, and 35 patients were excluded from the final analysis because of protocol violations. Forty-three patients received scopolamine and 47 patients received a placebo. INTERVENTION: A skin patch (scopolamine or placebo) was applied behind the right ear on the evening before operation and maintained for at least 24 hours postoperatively. MAIN OUTCOME MEASURES: The postoperative level of nausea assessed by the patient on a visual analogue scale, the frequency of vomiting and the frequency of antiemetic use. RESULTS: There was no significant difference in the level of nausea or in the frequency of emesis or use of antiemetics in the first 24 hours postoperatively between the control and study groups. Furthermore, there was no difference in the overall frequency of side effects. However, visual blurring was experienced by six patients in the study group compared with one in the control group (p = 0.082). CONCLUSION:Scopolamine administered transdermally before laparoscopic cholecystectomy does not reduce the frequency or level of nausea and vomiting postoperatively.
RCT Entities:
OBJECTIVE: To determine the efficacy of scopolamine administered transdermally before laparoscopic cholecystectomy as a means of reducing postoperative nausea and vomiting. DESIGN: A randomized, double-blind, placebo-controlled study. SETTING: A tertiary-care, university-affiliated hospital. PATIENTS: A volunteer sample of 125 men and women between 20 and 60 years of age scheduled to undergo elective laparoscopic cholecystectomy. Expectant or nursing mothers were excluded, and 35 patients were excluded from the final analysis because of protocol violations. Forty-three patients received scopolamine and 47 patients received a placebo. INTERVENTION: A skin patch (scopolamine or placebo) was applied behind the right ear on the evening before operation and maintained for at least 24 hours postoperatively. MAIN OUTCOME MEASURES: The postoperative level of nausea assessed by the patient on a visual analogue scale, the frequency of vomiting and the frequency of antiemetic use. RESULTS: There was no significant difference in the level of nausea or in the frequency of emesis or use of antiemetics in the first 24 hours postoperatively between the control and study groups. Furthermore, there was no difference in the overall frequency of side effects. However, visual blurring was experienced by six patients in the study group compared with one in the control group (p = 0.082). CONCLUSION:Scopolamine administered transdermally before laparoscopic cholecystectomy does not reduce the frequency or level of nausea and vomiting postoperatively.
Authors: Stephanie Weibel; Gerta Rücker; Leopold Hj Eberhart; Nathan L Pace; Hannah M Hartl; Olivia L Jordan; Debora Mayer; Manuel Riemer; Maximilian S Schaefer; Diana Raj; Insa Backhaus; Antonia Helf; Tobias Schlesinger; Peter Kienbaum; Peter Kranke Journal: Cochrane Database Syst Rev Date: 2020-10-19