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

Haisco Pharmaceutical Group Co., Ltd.1 site in 1 country135 target enrollmentJuly 26, 2021

ConditionsGynecological Outpatient Surgery

InterventionsCiprofol Propofol

DrugsCiprofol Propofol

Overview

Phase: Phase 3
Intervention: Ciprofol
Conditions: Gynecological Outpatient Surgery
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Enrollment: 135
Locations: 1
Primary Endpoint: Success rate of anesthesia
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 26, 2021

End Date

September 30, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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:
•Respiratory rate ≥ 10 and ≤ 24 breaths/min;
•Pulse oxygen saturation (SpO2) ≥ 95% when inhaling;
•Systolic blood pressure (SBP) ≥ 85 mmHg and ≤ 140 mmHg;
•Diastolic blood pressure (DBP) ≥ 50 mmHg and ≤ 90 mmHg;
•Heart rate ≥ 50 beats/min and ≤ 100 beats/min. (Note: For heart rate, the heart rate results of 12-ECG examination are used as the basis for judging whether the inclusion criteria are met.)

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:
•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;
•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;
•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.;
•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;
•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;
•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);

Arms & Interventions

Ciprofol

Ciprofol group：0.4/0.2mg/kg

Intervention: Ciprofol

Propofol

Propofol group：2.0/1.0mg/kg

Intervention: Propofol

Outcomes

Primary Outcomes

Success rate of anesthesia

Time Frame: Day 1

The proportion of subjects successfully anesthetized in all subjects of the group.

Secondary Outcomes

Time to full recovery:(Day 1)
Time to successful sedation/anesthetic induction(Day 1)
Sedation/anesthesia satisfaction, including satisfaction evaluation of subjects, anesthesiologists, and surgeons.(Day 1)
Time to discharge(Day 1)