BACKGROUND: The efficacy and tolerance of midazolam (Dormicum R) versus diazepam in lipid emulsion (Diazemuls R, Dumex) was evaluated in a randomized, controlled, double-blind trial in 200 patients undergoing total colonoscopy. METHODS:Diazepam in a dosage of 11.2+/-2.3 mg and midazolam in a dosage of 5.3+/-1.1 mg were given over 2 minutes. Flumazenil in a dosage of 0.2 mg within 15 seconds was administered to 50% of patients after procedure. RESULTS:Diazepam and midazolam were equivalent as judged by sedation, recovery time, patient tolerance, and ease of examination. The effect of flumazenil (Anexate R, Roche) on the recovery time was not significant as most patients were fully awake by the end of the procedure. Midazolam induced significantly more amnesia, and the score for recall of the pain score was significantly less after 14 days in the midazolam group. There were only minor complications in both groups. CONCLUSIONS: We conclude that midazolam can be used safely in relatively fit patients between 17 and 65 years old and that it is the drug of choice if amnesia is desirable. As sole premedication this drug was insufficient in 42% of the patients (pain score was greater than 3), especially in young women.
RCT Entities:
BACKGROUND: The efficacy and tolerance of midazolam (Dormicum R) versus diazepam in lipid emulsion (Diazemuls R, Dumex) was evaluated in a randomized, controlled, double-blind trial in 200 patients undergoing total colonoscopy. METHODS:Diazepam in a dosage of 11.2+/-2.3 mg and midazolam in a dosage of 5.3+/-1.1 mg were given over 2 minutes. Flumazenil in a dosage of 0.2 mg within 15 seconds was administered to 50% of patients after procedure. RESULTS:Diazepam and midazolam were equivalent as judged by sedation, recovery time, patient tolerance, and ease of examination. The effect of flumazenil (Anexate R, Roche) on the recovery time was not significant as most patients were fully awake by the end of the procedure. Midazolam induced significantly more amnesia, and the score for recall of the pain score was significantly less after 14 days in the midazolam group. There were only minor complications in both groups. CONCLUSIONS: We conclude that midazolam can be used safely in relatively fit patients between 17 and 65 years old and that it is the drug of choice if amnesia is desirable. As sole premedication this drug was insufficient in 42% of the patients (pain score was greater than 3), especially in young women.
Authors: L Rabeneck; R B Rumble; J Axler; A Smith; D Armstrong; C Vinden; P Belliveau; K Rhodes; C Zwaal; V Mai; P Dixon Journal: Can J Gastroenterol Date: 2007-11 Impact factor: 3.522