Balanced propofol sedation for therapeutic GI endoscopic procedures: a prospective, randomized study

BackgroundThere are few controlled studies on balanced propofol sedation (BPS) for therapeutic endoscopy.ObjectiveTo compare the safety and efficacy of BPS (propofol in combination with midazolam and meperidine) with conventional sedation (midazolam and meperidine) in patients undergoing therapeutic endoscopic procedures.DesignProspective, randomized, single-blinded study.SettingTertiary-care referral center.PatientsThis study involved 222 consecutive patients undergoing therapeutic EGD or ERCP from July 2009 to March 2010.InterventionConventional sedation or BPS by trained registered nurses under endoscopist supervision.Main Outcome MeasurementsRates of sedation-related cardiopulmonary complications and interruption of the procedures, procedure-related times, and assessments of health care providers (endoscopists and sedation nurses) and patients.ResultsThere were no significant differences between the BPS and conventional groups in the rates of cardiopulmonary complications (8.8% [9/102] vs 5.8% [6/104], respectively) and transient interruption of procedures (2.9% [3/102] vs 0% [0/104], respectively). No patient required assisted ventilation or premature termination of a procedure. BPS provided significantly higher health care provider satisfaction (mean ± SD 10-cm visual analog scale [VAS] score) compared with conventional sedation (endoscopists: 7.57 ± 2.61 vs 6.55 ± 2.99, respectively; P = .011; sedation nurses: 7.86 ± 2.31 vs 6.67 ± 2.90, respectively; P = .001). Patient cooperation was significantly better in the BPS group (VAS; endoscopists: 7.24 ± 2.97 vs 6.27 ± 3.09, P = .024; sedation nurses: 7.75 ± 2.30 vs 6.54 ± 2.99, P = .001).LimitationsSingle-center and single-blinded study.ConclusionCompared with conventional sedation, BPS provides higher health care provider satisfaction, better patient cooperation, and similar adverse event profiles in patients undergoing therapeutic endoscopic procedures.