Therapeutic advances in drug safety · 2026
Effect of ciprofol-assisted sedation on tourniquet-related responses in foot and ankle surgery: a randomized clinical trial.
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Ma Yaoyang, Zhu Bingqing, Wang Shudong, Lu Danjun, Yan Wenlong, Yu Yi, Cao Ying, Kang Fang, Li Juan
Аннотация
BACKGROUND: Tourniquet-related responses are a frequent clinical challenge during foot and ankle surgery under peripheral nerve block. Pharmacologic sedation and analgesia represent a common approach. Ciprofol, a novel intravenous sedative, remains underexplored in this surgical context.
OBJECTIVE: This study aimed to evaluate the impact of ciprofol-assisted sedation on tourniquet-related responses in patients undergoing foot and ankle surgery.
DESIGN: In total, 240 patients scheduled for foot and ankle procedures under peripheral nerve block with the use of a high thigh tourniquet were enrolled and randomized to undergo ciprofol (Group C) or propofol (Group P) sedation.
METHODS: In Group C, ciprofol was administered at an initial rate of 0.5 mg/(kg·h), with maintenance doses ranging from 0.5 to 2 mg/(kg·h) to maintain a BIS (bispectral index) between 65 and 80. Group P received an initial infusion of propofol at 2 mg/(kg·h), with maintenance between 2 and 8 mg/(kg·h). Primary outcomes included the incidence of intraoperative rescue analgesia and body movement. Secondary outcomes encompassed hemodynamic fluctuations, anesthesia success rate, injection-related discomfort, respiratory depression, blood pressure abnormalities, postoperative complications, and long-term complications.
RESULTS: There were no significant differences between groups in terms of the need for rescue analgesia or body movement during surgery. However, patients in the ciprofol group experienced significantly lower rates of injection pain and intraoperative hypotension relative to the propofol group (p < 0.05). No significant differences were found in postoperative adverse effects or long-term complications. In addition, both anesthesia completion rates and physician/patient satisfaction scores were similar between the two groups.
CONCLUSION: BIS-guided sedation with ciprofol during foot and ankle surgery provides equivalent control of tourniquet-related responses compared to propofol. However, ciprofol demonstrates superior intraoperative hemodynamic stability and a more favorable safety profile, including reduced adverse event rates.
TRIAL REGISTRATION: http://www.chictr.org.cn; ChiCTR2400083924; May 7, 2024.
OBJECTIVE: This study aimed to evaluate the impact of ciprofol-assisted sedation on tourniquet-related responses in patients undergoing foot and ankle surgery.
DESIGN: In total, 240 patients scheduled for foot and ankle procedures under peripheral nerve block with the use of a high thigh tourniquet were enrolled and randomized to undergo ciprofol (Group C) or propofol (Group P) sedation.
METHODS: In Group C, ciprofol was administered at an initial rate of 0.5 mg/(kg·h), with maintenance doses ranging from 0.5 to 2 mg/(kg·h) to maintain a BIS (bispectral index) between 65 and 80. Group P received an initial infusion of propofol at 2 mg/(kg·h), with maintenance between 2 and 8 mg/(kg·h). Primary outcomes included the incidence of intraoperative rescue analgesia and body movement. Secondary outcomes encompassed hemodynamic fluctuations, anesthesia success rate, injection-related discomfort, respiratory depression, blood pressure abnormalities, postoperative complications, and long-term complications.
RESULTS: There were no significant differences between groups in terms of the need for rescue analgesia or body movement during surgery. However, patients in the ciprofol group experienced significantly lower rates of injection pain and intraoperative hypotension relative to the propofol group (p < 0.05). No significant differences were found in postoperative adverse effects or long-term complications. In addition, both anesthesia completion rates and physician/patient satisfaction scores were similar between the two groups.
CONCLUSION: BIS-guided sedation with ciprofol during foot and ankle surgery provides equivalent control of tourniquet-related responses compared to propofol. However, ciprofol demonstrates superior intraoperative hemodynamic stability and a more favorable safety profile, including reduced adverse event rates.
TRIAL REGISTRATION: http://www.chictr.org.cn; ChiCTR2400083924; May 7, 2024.