Comparison of the efficacy and safety of ciprofol and propofol for ERCP anesthesia in older patients: A single-center randomized controlled clinical study.

STUDY OBJECTIVES

Ciprofol is a novel agonist at the gamma-aminobutyric acid-A (GABA) receptor, exhibiting better cardiovascular stability and rapid recovery. The objective of this study was to compare the efficacy and safety of ciprofol and propofol for endoscopic retrograde cholangiopancreatography (ERCP) anesthesia in older patients.

DESIGN

A single-center, randomized, parallel controlled clinical study.

SETTING

General Hospital of Northern Theater Command.

PATIENTS

We recruited 284 patients and intended to conduct ERCP from November 2021 to June 2022.

INTERVENTIONS

Patients scheduled for ERCP were randomly assigned to two groups (n = 142 each): ciprofol group (anesthesia induction 0.3-0.4 mg/kg, anesthesia maintenance 0.8-1.2 mg/kg/h) and propofol group (anesthesia induction 1.5-2.0 mg/kg, anesthesia maintenance 4-12 mg/kg/h).

MEASUREMENTS

The primary outcome was sedation success rate, defined as the proportion of patients with successful anesthesia induction. Secondary outcomes encompassed the time of successful induction, the time of complete recovery, the time of leaving the room and the incidence rate of adverse events (hypoxemia, hypotension and injection pain).

MAIN RESULTS

The success rate of sedation in both groups was 100 %. The 95 % CI of the difference of sedation success rate was (- 2.63 %, 2.63 %), and the lower limit was greater than the non-inferiority limit of -8 %.The time of successful sedation induction in ciprofol group (38.4 ± 6.5 s) was longer than that in propofol group (30.6 ± 6.2 s, p < 0.05).The time of complete recovery in ciprofol group (12.8 ± 5.8 min) was shorter than that in propofol group (16.9 ± 5.0 min, p < 0.05). The time of leaving the room in ciprofol group (21.8 ± 5.8 min) was shorter than those in propofol group (25.9 ± 5.1 min, p < 0.05). The incidence of injection pain in ciprofol group (2 %) was lower than that in the propofol group (25 %, p < 0.05). Other outcomes didn't show statistical differences.

CONCLUSIONS

Compared with propofol, ciprofol exhibited a comparable level of sedation in older patients undergoing ERCP, and recovery was safe and rapid with less injection pain.

TRIAL REGISTRATION

www.chictr.org.cn (Registration number ChiCTR2100053386, Registration date November 20, 2021).