Balanced propofol sedation for therapeutic GI endoscopic procedures: a prospective, randomized study - 11/08/11

Doi : 10.1016/j.gie.2010.09.035

Chang Kyun Lee, MD ^⁎, Suck-Ho Lee, MD, Il-Kwun Chung, MD, Tae Hoon Lee, MD, Sang-Heum Park, MD, Eun-Ok Kim, RN, Sae Hwan Lee, MD, Hong-Soo Kim, MD, Sun-Joo Kim, MD
Current affiliations: Division of Gastroenterology, Department of Internal Medicine (C.K.L.), Kyung Hee University School of Medicine, Seoul, Division of Gastroenterology, Department of Internal Medicine (S-H.L., I-K.C., T.H.L., S-H.P., E-O.K., S.H.L., H-S.K., S-J.K.), Soon Chun Hyang University College of Medicine, Cheonan Hospital, Cheonan, Korea

Reprint requests: Chang Kyun Lee, MD, PhD, Division of Gastroenterology, Department of Internal Medicine, Kyung Hee University School of Medicine, 1 Hoegi-dong, Dongdaemun-gu, Seoul, 130-702, Korea

Résumé

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.

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Abbreviations : ASA, BPS, SpO₂, VAS