A Phase 4 interventional study of Ciprofol and Propofol in Bariatric Surgery, sponsored by The Third People's Hospital of Chengdu. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by The Third People's Hospital of Chengdu · Phase 4, Interventional, and Treatment
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.
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 Third People's Hospital of Chengdu is the lead sponsor of 12 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental drug: Ciprofol; Dosage form: injection; Specification: 20ml: 50mg; Frequency and duration: intravenous infusion with micropump, anesthesia induction dose 0.4-0.5mg/kg, Administration for 30s (± 5S)
Drug: Ciprofol
Experimental drug: Propofol; Dosage form: injection; Specification: 20ml: 200mg; Frequency and duration: intravenous infusion with micropump, anesthesia induction dose 2-2.5mg/kg, Administration for 30s (± 5S)
Drug: Propofol
Ciprofol (0.4-0.5mg/kg) for anesthesia induction
Also known as: Ciprofol Group, Experimental Group
propofol(2-2.5mg/kg) for anesthesia induction
Also known as: Propofol Group, Control Group
The rate of successful anesthesia induction
The criteria for success are to meet the following two requirements at the same time: 1) successful induction (i.e. improved investigator awake / sedation score (MOAA / S) ≤ 1) after the administration of the study drug (at most 2 additional times are allowed); 2) No alternative anesthetics were used.
Time frame: Through study completion, an average of 1 year
Time to LOC
Time from initial administration of study drug to loss of consciousness
Time frame: During anesthesia induction, an average of 10 minutes
Time to disappearance of eyelash reflex
Time from initial administration of study drug to disappearance of eyelash reflex
Time frame: During anesthesia induction, an average of 10 minutes
BIS
Changes in bispectral index(BIS) values during anesthesia induction
Time frame: During anesthesia induction, an average of 10 minutes
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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The Third People's Hospital of Chengdu