Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries
NCT04958746 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135
Last updated 2022-06-02
Summary
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.
Conditions
- Gynecological Outpatient Surgery
Interventions
- DRUG
-
Ciprofol
intravenous bolus
- DRUG
-
Propofol
intravenous bolus
Sponsors & Collaborators
-
Haisco Pharmaceutical Group Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Dongxin Wang · Peking University First Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-26
- Primary Completion
- 2021-09-29
- Completion
- 2021-09-30
Countries
- China
Study Locations
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