Efficacy and Safety of Ciprofol in Laparoscopic Sleeve Gastrectomy

Bariatric Surgery Clinical Trial

Official title: Efficacy and Safety of Ciprofol for the Induction of General Anesthesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

Status Recruiting

Clinical Trial Summary

To evaluate the efficacy and safety of ciprofol for the induction of general anesthesia in obese patients undergoing laparoscopic sleeve gastrectomy. A randomized, parallel, propofol injection positive control study will be conducted to select obese patients who will undergo laparoscopic sleeve gastrectomy in the author's hospital. To evaluate the efficacy and safety, the main observation index, secondary observation indexes, safety evaluation indexes, and the incidence of postoperative adverse reactions will be recorded and compared between the two groups.

Clinical Trial Description

To evaluate the efficacy and safety of ciprofol for the induction of general anesthesia in obese patients undergoing laparoscopic sleeve gastrectomy. A randomized, parallel, propofol injection positive control study will be conducted to select obese patients who will undergo laparoscopic sleeve gastrectomy in the author's hospital. To evaluate the efficacy and safety, the following indexes will be recorded and compared between the two groups.

• The main observation index：(1) The rate of successful anesthesia induction

• Secondary observation indexex：(1) Time from initial administration of study drug to loss of consciousness; (2) Time from initial administration of study drug to disappearance of eyelash reflex; (3) Changes in bispectral index(BIS) values during anesthesia induction

• Safety evaluation indexes：(1) Adverse events; (2) Intubation response rate; (3) Vital signs; (4) Evaluation of injection pain

• Adverse events to be focused on：(1)The incidence of blood pressure reduction requiring treatment during anesthesia induction; (2) The incidence of respiratory depression ;

Related Conditions & MeSH terms

• Bariatric Surgery

• NCT number: NCT05522998
• Study type: Interventional
• Source: The Third People's Hospital of Chengdu
• Contact: Xiaowei Chi, M.D.
• Phone: +8613708085545
• Email: mzkchixiaowei@yeah.net
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Completion date: September 30, 2024