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Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries

A Multi-Center, Randomized, Double-Blind, Propofol Parallel-Controlled 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•Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Patient needing gynecological outpatient surgery under general anesthesia without endotracheal intubation;
•2. Female, aged between 18-65 (inclusive);
•3. American Society of Anesthesiologists (ASA) Class I- II
•4. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
•5. Vital signs during the screening period meet the following criteria:
•1. Respiratory rate ≥ 10 and ≤ 24 breaths/min;
•2. Pulse oxygen saturation (SpO2) ≥ 95% when inhaling;
•3. Systolic blood pressure (SBP) ≥ 85 mmHg and ≤ 140 mmHg;
•4. Diastolic blood pressure (DBP) ≥ 50 mmHg and ≤ 90 mmHg;
•6. 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

•1. Patients with contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
•2. 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;
•3. Patients with positive urine HCG or blood HCG (except abortion, dilatation and curettage, other outpatient surgeries for termination of pregnancy);
•4. Patients having the following medical history or evidence prior to screening, which may increase sedation/anesthesia risk:
•1. History of cardiovascular diseases: Uncontrolled hypertension or SBP \> 140 mmHg and/or DBP \> 90 mmHg despite antihypertensive treatment, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months prior to screening, history of tachycardia/bradycardia requiring medication, third-degree atrioventricular block or QTcF interval ≥ 450 ms (Fridericia's correction formula) during screening;
•2. Respiratory system disorders: Respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months prior to screening, acute respiratory tract infection with any one of the obvious symptoms such as fever, wheezing, or productive cough within 1 week prior to screening;
•3. History of neurological and mental disorders: history of craniocerebral injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysm, or cerebrovascular accident; history of schizophrenia, mania, chronic use of antipsychotics, cognitive impairment, etc.;
•4. History of gastrointestinal diseases: history of gastrointestinal retention, active hemorrhage, gastroesophageal reflux or obstruction, etc. which may cause reflux and aspiration, as per the judgment of the investigator;
•5. History of uncontrolled and clinically significant diseases in such as liver, kidney, blood system, nervous system, or metabolic system judged by the investigator to be unsuitable for this trial;
•6. History of alcohol abuse within 3 months prior to screening, abuse defined as average of \> 2 units of alcohol per day (1 unit = 360 mL of beer or 45 mL of liquor with 40% alcohol or 150 mL of wine);
+20 more criteria

Locations (1)

Peking University First Hospital

Beijing, China

Key Dates

Start Date

July 26, 2021

Primary Completion Date

September 29, 2021

Completion Date

September 30, 2021

Last Updated

June 2, 2022

Enrollment

135

ACTUAL participants

Conditions

Gynecological Outpatient Surgery

Interventions

Ciprofol

DRUG

Propofol

DRUG