BackgroundPatients should be closely monitored during procedures under sedation outside the operating room, but it is unclear which type of monitoring is best. We investigated the efficacy and safety of BIS monitoring vs conventional monitoring for sedation during colonoscopy. MethodsWe performed a double-blind clinical trial in 180 patients undergoing elective colonoscopy. Patients were randomized to 1)the BIS group or 2)a control group, in which sedation was monitored with a BIS monitor or the Ramsay Sedation Score, respectively. The primary outcome was the rate of sedation-induced adverse events in both groups. Secondary outcomes were the characteristics of patients who developed adverse events, and duration of colonoscopy when these events occurred, propofol and remifentanil dosage, and patient satisfaction. ResultsUnivariate analysis showed fewer cardiopulmonary complications in the BIS group (41.11% vs 57.78% in controls; P=.02). Multivariate analysis found a significantly higher risk of adverse events in older patients (95%CI: 1.013-1.091; P=.0087) and in men (95%CI: 1.129-7.668; P=.0272). These events were observed at the hepatic flexure. No significant differences between propofol or remifentanil dosage, use of rescue medication, and patient satisfaction were observed between groups. ConclusionsOur data suggest that BIS monitoring during sedation in scheduled colonoscopies reduces adverse respiratory events. Although its routine use in sedation does not appear to be warranted, clinicians should take steps to identify patients with a higher risk of complications who might benefit from this type of monitoring.