BACKGROUND: There are few controlled studies on balanced propofol sedation (BPS) for therapeutic endoscopy. OBJECTIVE: To 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. DESIGN: Prospective, randomized, single-blinded study. SETTING: Tertiary-care referral center. PATIENTS: This study involved 222 consecutive patients undergoing therapeutic EGD or ERCP from July 2009 to March 2010. INTERVENTION: Conventional sedation or BPS by trained registered nurses under endoscopist supervision. MAIN OUTCOME MEASUREMENTS: Rates 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. RESULTS: There 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). LIMITATIONS: Single-center and single-blinded study. CONCLUSION: Compared with conventional sedation, BPS provides higher health care provider satisfaction, better patient cooperation, and similar adverse event profiles in patients undergoing therapeutic endoscopic procedures.
RCT Entities:
BACKGROUND: There are few controlled studies on balanced propofol sedation (BPS) for therapeutic endoscopy. OBJECTIVE: To 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. DESIGN: Prospective, randomized, single-blinded study. SETTING: Tertiary-care referral center. PATIENTS: This study involved 222 consecutive patients undergoing therapeutic EGD or ERCP from July 2009 to March 2010. INTERVENTION: Conventional sedation or BPS by trained registered nurses under endoscopist supervision. MAIN OUTCOME MEASUREMENTS: Rates 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. RESULTS: There 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). LIMITATIONS: Single-center and single-blinded study. CONCLUSION: Compared with conventional sedation, BPS provides higher health care provider satisfaction, better patient cooperation, and similar adverse event profiles in patients undergoing therapeutic endoscopic procedures.
Authors: Sachin Wani; Riad Azar; Christine E Hovis; Robert M Hovis; Gregory A Cote; Matthew Hall; Lawrence Waldbaum; Vladimir Kushnir; Dayna Early; Daniel K Mullady; Faris Murad; Steven A Edmundowicz; Sreenivasa S Jonnalagadda Journal: Gastrointest Endosc Date: 2011-12 Impact factor: 9.427
Authors: John K Triantafillidis; Emmanuel Merikas; Dimitrios Nikolakis; Apostolos E Papalois Journal: World J Gastroenterol Date: 2013-01-28 Impact factor: 5.742