Abstract
Background
Ciprofol(HSK3486) is a novel 2,6-disubstituted phenol derivate, a short-acting intravenous sedative, which has similar efficacy characteristics as propofol with less incidence of side effect. Both ciprofol and propofol are often used in outpatient hysteroscopic surgery for sedation. However, the relative potency of these two drugs has not been fully determined in this context.
Methods
The effective dose in 50% of subjects(ED50) value for ciprofol and propofol were calculated by Up-and-Down Sequential Allocation Method. A total of 60 parturients undergoing daytime hysteroscopy were randomly divided into two groups, which were intravenously injected with ciprofol at an initial dose of 0.4mg/kg (group C) or propofol at an initial dose of 2mg/kg (group P) at 2 min after intravenous injection of sufentanil 0.15ug/kg. A successful response is defined as the absence of patient movement in the case of cervical dilation. Conversely, the presence of patient movement is defined as failure. After successful or failed responses, each follow-up patient in the corresponding group was reduced or increased with propofol 0.5mg/kg or ciprofol 0.1mg/kg, respectively.
Results
The estimated ED50 value for ciprofol and propofol in restraining reaction of hysteroscopy dilatation was 0.444 mg/kg (95% CI, 0.385-0.503mg/kg) and 1.985 mg/kg (95% CI, 1.801–2.170 mg/kg), respectively. The incidence of respiratory depression, hypoxemia and injection pain in ciprofol was significantly lower than those in propofol(P < 0.05).
Conclusion
The ED50 of ciprofol and propofol in preventing hysteroscopy dilatation reaction was 0.444 mg/kg (95% CI, 0.385-0.503mg/kg) and1.985 mg/kg (95% CI, 1.801–2.170 mg/kg) for outpatient hysteroscopy. The potency-ratio of ciprofol and propofol observed in our study was 1.0:4.5(95%CI,1:3.9-1:5.1).
Trial registration
The study was approved by the Ethical Committee of Women’s Hospital, Zhejiang University School of Medicine (Hangzhou, China) (No. IRB-20220157-R) and was registered at the Chinese Clinical Trials.gov (NO. ChiCTR2200065954) before patient enrollment. All participants signed an informed consent form.
Trial registration
The study was registered at Chinese Clinical Trial Registry http://www.chictr.org.cn/ (Registration date:19/11/22; Trial ID: ChiCTR2200065954).