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 | Completed Phase 3

• 1 other identifier: HSK3486-308
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecological Outpatient Surgery

Outcome Measures

Primary Outcomes (1)

• Success rate of anesthesia

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

  Day 1

Secondary Outcomes (4)

• Time to successful sedation/anesthetic induction

  Day 1

• Time to full recovery:

  Day 1

• Time to discharge

  Day 1

• Sedation/anesthesia satisfaction, including satisfaction evaluation of subjects, anesthesiologists, and surgeons.

  Day 1

Study Arms (2)

Ciprofol

EXPERIMENTAL

Ciprofol group：0.4/0.2mg/kg

Drug: Ciprofol

Propofol

PLACEBO COMPARATOR

Propofol group：2.0/1.0mg/kg

Drug: Propofol

Interventions

Ciprofol DRUG

intravenous bolus

Ciprofol

Propofol DRUG

intravenous bolus

Propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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);
• History of drug abuse within 3 months prior to screening;
• Serious infection, trauma, or major surgery within 4 weeks prior to screening.
• Patients with the following airway management risks at screening:
• Asthma history, and stridor;
• Sleep apnea syndrome;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 38716419 DERIVED

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Dongxin Wang

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 12, 2021
• Study Start: July 26, 2021
• Primary Completion: September 29, 2021
• Study Completion: September 30, 2021
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

CN (1)