Published online May 21, 2015. doi: 10.3748/wjg.v21.i19.5995
Peer-review started: November 18, 2014
First decision: December 26, 2014
Revised: January 15, 2015
Accepted: February 11, 2015
Article in press: February 11, 2015
Published online: May 21, 2015
Processing time: 183 Days and 7.9 Hours
AIM: To assess the efficacy and safety of a patient-positioning device (EZ-FIX) for endoscopic retrograde cholangiopancreatography (ERCP).
METHODS: A total of 105 patients were randomized to the EZ-FIX (n = 53) or non-EZ-FIX (n = 52) group in this prospective study. Midazolam and propofol, titrated to provide an adequate level of sedation during therapeutic ERCP, were administered by trained registered nurses under endoscopist supervision. Primary outcome measures were the total dose of propofol and sedative-related complications, including hypoxia and hypotension. Secondary outcome measures were recovery time and sedation satisfaction of the endoscopist, nurses, and patients.
RESULTS: There was no significant difference in the rate of hypoxia, but there was a statistical trend (EX-FIX group; n = 4, 7.55%, control group; n = 6, 11.53%, P = 0.06). The mean total dose of propofol was lower in the EZ-FIX group than in the non-EZ-FIX group (89.43 ± 49.8 mg vs 112.4 ± 53.8 mg, P = 0.025). In addition, the EZ-FIX group had a shorter mean recovery time (11.23 ± 4.61 mg vs 14.96 ± 5.12 mg, P < 0.001). Sedation satisfaction of the endoscopist and nurses was higher in the EX-FIX group than in the non-EZ-FIX group. Technical success rates of the procedure were 96.23% and 96.15%, respectively (P = 0.856). Procedure-related complications did not differ by group (11.32% vs 13.46%, respectively, P = 0.735).
CONCLUSION: Using EZ-FIX reduced the total dose of propofol and the recovery time, and increased the satisfaction of the endoscopist and nurses.
Core tip: Although the incidence of sedation-related complications is low, it is closely associated with endoscopy-related morbidity and mortality. Many studies on the efficacy and safety of various sedative drugs have been conducted, but none used a patient-positioning device. We planned this study to improve the safety and efficacy of sedation during endoscopy by using a patient-positioning device (EZ-FIX).