Efficacy and safety of different doses of ciprofol for general anesthesia induction in elderly patients undergoing hip replacement surgery: a randomized, double-blind, controlled clinical trial
Abstract
Background: Ciprofol can be used for general anesthesia induction in elderly patients undergoing major noncardiac surgery. This trial aimed to compare the efficacy and safety of three more precise doses of ciprofol and explore the optimal dose for induction in elderly patients undergoing hip replacement surgery. Methods: This trial was a prospective, randomized, controlled trial. One hundred and twenty elderly patients scheduled for hip replacement surgery were randomly divided into four groups for general anesthesia induction: PROP group (propofol 1.5 mg/kg), CIP1 (ciprofol 0.25 mg/kg), CIP2 (ciprofol 0.30 mg/kg), and CIP3 group (ciprofol 0.35 mg/kg). The primary outcome was the induction success rate of general anesthesia. The secondary outcomes included the induction success time, eyelash reflex disappearance time, the number of additional anesthetics required and the total dose of successful induction. The safety indicators included the incidence of adverse events such as hypotension, hypertension, tachycardia, bradycardia, hypoxemia, injection pain and body movements. Results: The success rate of general anesthesia induction in the four groups were 100%. There was no statistically significant difference in the induction success time and eyelash reflex disappearance time between the CIP3 group and the PROP group. However, both of these times increased significantly in the CIP1 group and the CIP2 group, and the results showed statistically significant differences. The number of patients who required top-up doses and doses of top- up dose in the CIP1 and CIP2 groups were significantly greater than in the PROP and CIP3 groups. The total dose of successful induction in the PROP group was 4-5 times higher than that of the ciprofol groups. The incidence of hypotension in ciprofol groups was significantly lower than in the propofol group. There was no statistically significant difference in the incidence of hypertension, tachycardia and bradycardia among the four groups. The incidence of injection pain in the PROP group was 50%, whereas no injection pain was reported in three CIP groups. All subjects did not experience body movements and respiratory depression. Conclusions: Ciprofol (0.25-0.35mg/kg) could be safely and effectively used for general anesthesia induction in elderly patients undergoing hip replacement surgery. The anesthetic efficacy of 0.35mg/kg ciprofol was not inferior to that of 1.5mg/kg propofol and had higher safety and comfort.Copyright (c) 2025 Xiao Tian, Haojun Sun, Yugang Diao, Bin Zou, Zitong Xu, Chunlin Yao, Lin Li

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