BACKGROUND: The diagnostic upper gastrointestinal endoscopy (UGI) is a safe procedure although 50% to 60% morbidity and mortality due to cardiopulmonary complications. OBJECTIVE: To compare safety and efficacy of dexmedetomidine vs. midazolam in UGI. METHODS: We conducted a randomized controlled, double-blind, clinical trial to compare the two drugs. Patients with an indication of UGI were randomized to receive sedation with dexmedetomidine or midazolam during the procedure. We compared age, sex, physical status (ASA), body mass index (BMI), degree of sedation (Ramsay scale), recovery time and degree of satisfaction with the procedure. RESULTS:Forty patients with an indication of UGI were included (20 in each arm). Both groups showed a similar distribution by sex, age, BMI and ASA physical status. The level of sedation was similar starting and ending the procedure according to the Ramsay scale. The dexmedetomidine group had a shorter recovery time (7.1 vs. 15.8 min, p <0.05) and satisfaction (9.9 vs. 9.0, p <0.05). Adverse effects occurred in similar proportions in both groups. CONCLUSIONS:Midazolam and dexmedetomidine are suitable for endoscopic procedures of upper digestive tract. Dexmedetomidine offers shorter recovery time and better patient's satisfaction.
RCT Entities:
BACKGROUND: The diagnostic upper gastrointestinal endoscopy (UGI) is a safe procedure although 50% to 60% morbidity and mortality due to cardiopulmonary complications. OBJECTIVE: To compare safety and efficacy of dexmedetomidine vs. midazolam in UGI. METHODS: We conducted a randomized controlled, double-blind, clinical trial to compare the two drugs. Patients with an indication of UGI were randomized to receive sedation with dexmedetomidine or midazolam during the procedure. We compared age, sex, physical status (ASA), body mass index (BMI), degree of sedation (Ramsay scale), recovery time and degree of satisfaction with the procedure. RESULTS: Forty patients with an indication of UGI were included (20 in each arm). Both groups showed a similar distribution by sex, age, BMI and ASA physical status. The level of sedation was similar starting and ending the procedure according to the Ramsay scale. The dexmedetomidine group had a shorter recovery time (7.1 vs. 15.8 min, p <0.05) and satisfaction (9.9 vs. 9.0, p <0.05). Adverse effects occurred in similar proportions in both groups. CONCLUSIONS:Midazolam and dexmedetomidine are suitable for endoscopic procedures of upper digestive tract. Dexmedetomidine offers shorter recovery time and better patient's satisfaction.