A Study to Evaluate the Efficacy and Safety of HSK3486 in the Induction of General Anesthesia

NCT04511728 | Completed Phase 3

• 1 other identifier: HSK3486-306
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, randomized, single-blind, propofol injectable emulsion parallel-controlled Phase III clinical study. A total of patients undergoing elective surgery are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.

Conditions

Induction and Maintenance of General Anesthesia

Outcome Measures

Primary Outcomes (1)

• Success rate of anesthesia maintenance

  During the maintenance of anesthesia, the subject is not recovered and no remedial anesthetic is used

  During maintenance of general anesthesia on day 1

Secondary Outcomes (6)

• Success rate of anesthesia induction

  During induction of general anesthesia on day 1

• Percentage of time from the beginning of surgical skin incision to the end of surgery

  During maintenance of general anesthesia on day 1

• Time to recovery from anesthesia

  A period of time from discontinuation of the study drug to recovery after the end of surgery on day 1

• Time to respiratory recovery

  A period of time from discontinuation of the study drug to respiratory recovery after the end of surgery on day 1

• Time from discontinuation of the study drug to 3 consecutive Aldrete score ≥ 9.

  A period of time from discontinuation of the study drug to 3 consecutive Aldrete score ≥ 9 on day 1

Other Outcomes (1)

• Concentrations of HSK3486 and propofol in blood samples (sporadic sampling).

  The end of the induction administration (to start of the maintenance administration) to 1~6 hours post-dose

Study Arms (2)

HSK3486

EXPERIMENTAL

Drug: HSK3486

Propofol

ACTIVE COMPARATOR

Drug: Propofol

Interventions

HSK3486 DRUG

The initial Induction dose of HSK3486 is 0.4 mg/kg. The initial maintenance dose of HSK3486 is 0.8 mg/kg/h

HSK3486

Propofol DRUG

The initial Induction dose of propofol is 2.0 mg/kg. The initial maintenance dose of propofol is 5.0 mg/kg/h

Propofol

Eligibility Criteria

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

You may qualify if:

• In-patients undergoing non-emergency, non-cardiothoracic, and non-extracerebral elective surgeries with expected operation time ≥ 1 h and requiring tracheal intubation under general anesthesia (patients whose surgery type may affect the collection of BIS parameter should not be included);
• Male or female, age ≥ 18 and ≤ 65 years old;
• American Society of Anesthesiologists (ASA) class I-III;
• Body mass index (BMI) ≥ 18 and ≤ 30 kg/m\^2;
• Vital signs in the screening period meeting the following criteria:
• Respiration rate ≥ 10 and ≤ 24 breaths/min;
• SpO2 while breathing ≥ 95%;
• Systolic blood pressure ≥ 90 mmHg and ≤ 160 mmHg;
• Diastolic blood pressure ≥ 60 mmHg and ≤ 100 mmHg;
• Heart rate ≥ 55 and ≤ 100 bpm. (Note: The heart rate is judged by the results of ECG monitoring after signing the ICF, and the heart rate results of 12-lead ECG examination are not used as the basis for judgment.)
• Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with study protocol.

You may not qualify if:

• Patients with contraindications to general anesthesia or previous history of anesthesia accidents;
• Known hypersensitivity to excipients and ingredients found in propofol injection and HSK3486 injectable emulsion (soybean oil, glycerin, triglycerides, egg lecithin, sodium oleate, and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, and sugammadex sodium; cross-reactivity to halogenated anesthetics, jaundice or unexplained fever from previous use of halogenated anesthetics; contraindications to propofol;
• The following disease history or evidence that increases the risk of sedation/anesthesia is collected before/during screening:
• History of cardiovascular diseases: uncontrolled hypertension or SBP \> 160 mmHg and/or DBP \> 100 mmHg after treatment with antihypertensive drugs, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction, tachycardia/bradycardia requiring medication, or third-degree atrioventricular block within 6 months before screening, or QTcF interval of ≥ 450 ms (corrected using Fridricia's formula) during the screening period;
• History of respiratory diseases: respiratory insufficiency, history of obstructive pulmonary disorders, history of bronchospasm requiring treatment within 3 months before screening, and acute respiratory infection with one of the symptoms such as obvious fever, wheezing or productive cough within 1 week before the baseline period;
• History of neurological and psychiatric disorders: craniocerebral injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysms, cerebrovascular accidents; or schizophrenia, mania, long-term use of psychotropic drugs, history of cognitive impairment, etc.;
• History of gastrointestinal tract diseases: gastrointestinal retention, active bleeding, gastroesophageal reflux or obstruction, etc. which may cause reflux and aspiration judged by the investigator;
• Diabetic patients with uncontrolled blood glucose (fasting blood glucose ≥ 11.1 mmol/L, and/or random blood glucose ≥ 13.6 mmol/L);
• Patient with a history of uncontrolled and clinically significant liver, kidney, blood system, nervous system or metabolic system diseases judged by the investigator to be unsuitable for this trial;
• History of alcohol abuse within 3 months prior to screening, where alcohol abuse refers to daily alcohol drinking \> 2 units of alcohol (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.
• Any of the following respiratory management risks before/during screening:
• Asthma history and stridor;
• Sleep apnea syndrome;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

West China Hospital，Sichuan University

Chengdu, China

Location

Related Publications (1)

• Liang P, Dai M, Wang X, Wang D, Yang M, Lin X, Zou X, Jiang K, Li Y, Wang L, Shangguan W, Ren J, He H. Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial. Eur J Anaesthesiol. 2023 Jun 1;40(6):399-406. doi: 10.1097/EJA.0000000000001799. Epub 2023 Jan 19.

  PMID: 36647565 DERIVED

MeSH Terms

Interventions

HSK3486; Propofol

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 13, 2020
• Study Start: November 24, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 25, 2021
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

CN (1)