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This study is a multi-center, randomized, double-blind, Propofol parallel-controlled phase III clinical study, with the primary objective of evaluating the efficacy of Ciprofol vs. Propofol for the induction of sedation/anesthesia in subjects undergoing gynecological outpatient surgeries and secondary objective of evaluating the safety of Ciprofol in subjects undergoing gynecological outpatient surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofol | Experimental | Ciprofol group:0.4/0.2mg/kg |
|
| Propofol | Placebo Comparator | Propofol group:2.0/1.0mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofol | Drug | intravenous bolus |
| |
| Propofol |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of anesthesia | The proportion of subjects successfully anesthetized in all subjects of the group. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to successful sedation/anesthetic induction | Time from the initial administration of the investigational drug to the first time when MOAA/S is ≤ 1 | Day 1 |
| Time to full recovery: | Time from the last administration of the investigational drug to the first of 3 consecutive MOAA/S scores = 5 |
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Inclusion Criteria:
Patient needing gynecological outpatient surgery under general anesthesia without endotracheal intubation;
Female, aged between 18-65 (inclusive);
American Society of Anesthesiologists (ASA) Class I- II
Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
Vital signs during the screening period meet the following criteria:
Capable of understanding the procedure and method of this study, willing to sign an informed consent form and to complete this study in strict accordance with the study protocol.
Exclusion Criteria:
Patients with contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
Known sensitivity to Propofol Injection, Ciprofol Injection, the excipients in the investigational drugs (soybean oil, glycerin, triglyceride, egg lecithin, purified lecithin, sodium oleate, sodium hydroxide and disodium edetate), and opioids or any ingredient of opioids; contraindications to Propofol;
Patients with positive urine HCG or blood HCG (except abortion, dilatation and curettage, other outpatient surgeries for termination of pregnancy);
Patients having the following medical history or evidence prior to screening, which may increase sedation/anesthesia risk:
Patients with the following airway management risks at screening:
Receiving any one of the following medications or treatments at screening:
Patient whose laboratory parameters measured at screening meet any of the following criteria and are verified through reexamination:
Breastfeeding females; women of child-bearing potential who are unwilling to use contraception during the trial; or subjects who are planning pregnancy within 1 month after completion of the trial.
Subject judged by the investigator to have any other factors unsuitable for participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Dongxin Wang | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38716419 | Derived | Xu J, Yang M, Zeng Y, Zou XH, Ren JH, Xia Z, Xie HH, Yu YH, Xu MJ, Chen W, Wang DX. Efficacy and safety of ciprofol for sedation in outpatient gynecological procedures: a phase III multicenter randomized trial. Front Med (Lausanne). 2024 Apr 23;11:1360508. doi: 10.3389/fmed.2024.1360508. eCollection 2024. |
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| Drug |
intravenous bolus |
|
| Day 1 |
| Time to discharge | The time from the last administration of the investigational products to the first of 3 consecutive Aldrete scores of ≥ 9 | Day 1 |
| Sedation/anesthesia satisfaction, including satisfaction evaluation of subjects, anesthesiologists, and surgeons. | Day 1 |
| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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