Efficacy and safety of remimazolam besylate plus propofol for sedation in endoscopic retrograde cholangiopancreatography: a randomized controlled study.

OBJECTIVE

To explore the efficacy and safety of the new anesthetic remimazolam besylate combined with propofol in anesthesia for endoscopic retrograde cholangiopancreatography (ERCP).

METHODS

A total of 60 patients who underwent selective ERCP in Shifang People's Hospital were selected as the research objects. They were randomly divided into the control group (C group) and the remimazolam group (R group), with 30 cases in each group. C group was given normal saline + propofol, and R group was given remimazolam + propofol. The hemodynamic indexes, propofol dosage, sedation and analgesia effects, patient and doctor satisfaction, success rate of operation and perioperative complications of the two groups were compared.

RESULTS

The perioperative heart rate (HR) and mean arterial pressure (MAP) of R group were more stable than those of C group (P < 0.05) throughout the procedure. The dosage of propofol in R group was significantly less than that in C group (366.68 ± 69.22 mg vs. 436.34 ± 171.28 mg, P < 0.05). At each time point, the mean RSS score was higher in group R and the mean VAS score was lower (RSS: 5.03 ± 0.84 vs. 3.95 ± 0.81; VAS: 1.63 ± 1.18 vs. 2.63 ± 1.15, P < 0.05). The doctor satisfaction score of R group was significantly higher than that of C group (P < 0.05), while there was no significant difference in patient satisfaction score between the two groups (P > 0.05). There was no significant difference in the success rate of operation between the two groups (P > 0.05). The total incidence of perioperative complications in R group was significantly lower than that in C group (P < 0.05).

CONCLUSION

The application of remimazolam besylate combined with propofol in ERCP can reduce the dosage of propofol, maintain stable hemodynamics, improve sedation and analgesia effects, enhance patient and doctor satisfaction, and reduce the incidence of perioperative complications, which is an effective and safe anesthetic scheme.

CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/, identifier ChiCTR2300 073982.