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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofol Group | Experimental | 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) |
|
| Propofol Group | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofol | Drug | Ciprofol (0.4-0.5mg/kg) for anesthesia induction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to LOC | Time from initial administration of study drug to loss of consciousness | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaowei Chi, M.D. | Third People's Hospital of Chengdu, Southwest Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third People's Hospital of Chengdu, Affiliated Hospital of Southwest Jiaotong University | Chengdu | Sichuan | 610031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40705792 | Derived | Chi X, Xu Y, Li Q, Xia K, Fu Q. Efficacy and safety of ciprofol for the induction of general anesthesia in patients with obesity undergoing laparoscopic sleeve gastrectomy: A double-blind randomized, controlled study. PLoS One. 2025 Jul 24;20(7):e0329005. doi: 10.1371/journal.pone.0329005. eCollection 2025. |
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| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| D015742 | Propofol |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | propofol(2-2.5mg/kg) for anesthesia induction |
|
|
| During anesthesia induction, an average of 10 minutes |
| BIS | Changes in bispectral index(BIS) values during anesthesia induction | During anesthesia induction, an average of 10 minutes |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |