A Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of Sedation/Anesthesia in Subjects Undergoing Fiberoptic Bronchoscopy

Sichuan Haisco Pharmaceutical Group Co., Ltd1 site in 1 country267 target enrollmentDecember 6, 2019

ConditionsSedation or Anesthesia

InterventionsHSK3486 Propofol

DrugsHSK3486 Propofol

Overview

Phase: Phase 3
Intervention: HSK3486
Conditions: Sedation or Anesthesia
Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd
Enrollment: 267
Locations: 1
Primary Endpoint: Success rate of fiberoptic bronchoscopy. A successful diagnosis/treatment should meet both of the following:
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial. Around 260 eligible subjects are planned to be enrolled and randomized in a 1:1 ratio to either the HSK3486 arm or propofol arm. The main objective is to evaluate the efficacy of HSK3486 vs. propofol for the induction of sedation/anesthesia in subjects undergoing fiberoptic bronchoscopy.

Registry

clinicaltrials.gov

Start Date

December 6, 2019

End Date

July 27, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1.Subjects receiving laryngeal mask airway-assisted diagnostic and/or therapeutic fiberoptic bronchoscopy; 2.Male or female, ASA I-III, ≥ 18 and \< 80 years old; 3.Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2; 4.Respiratory rate ≥ 10 and ≤ 24 bpm; SpO2 ≥ 93%; SBP ≥ 90 mmHg; DBP ≥ 55 mmHg; HR ≥ 50 and ≤ 100 bpm during screening and baseline periods; 5.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

•Patients with contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
•Patient known to be allergic to eggs, soy products, opioids and their antidotes, and propofol; patient having contraindications to propofol, opioids and their antidotes;
•Patients who have undergone endotracheal intubation and/or mechanical ventilation prior to diagnostic or therapeutic bronchoscopy;
•Medical history or evidence of any of the following prior to screening/at baseline, which may increase sedation/anesthesia risk:
•History of cardiovascular diseases: uncontrolled hypertension \[systolic blood pressure (SBP) ≥170 mmHg and/or diastolic blood pressure (DBP) ≥105 mmHg without treatment, or SBP \> 160 mmHg and/or DBP \>100 mmHg after antihypertensive treatment\], aneurysm, severe arrhythmia, heart failure, Adams-stokes syndrome, New York Heart Association (NYHA) Class ≥ III, severe superior vena cava syndrome, pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medical treatment, II-III degree atrioventricular block (excluding patients with pacemakers) or QTcF interval ≥ 450 ms \[during screening only (corrected using Fredericia's formula1)\];
•History of respiratory diseases: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, history of tracheoesophageal fistula or airway tear, severe respiratory infection within 2 weeks prior to screening;
•History of neurological and psychiatric disorders: craniocerebral injury, possible convulsions, intracranial hypertension, cerebral aneurysms, history of cerebrovascular accidents; schizophrenia, mania, insanity, long-term use of psychotropic drugs, and history of cognitive dysfunction;
•History of gastrointestinal diseases: gastrointestinal retention, active hemorrhage, or history of gastroesophageal reflux or obstruction that may lead to aspiration;
•History of uncontrolled clinically significant liver, kidney, blood system, nervous system or metabolic system diseases judged by the investigator to be probably unsuitable for involvement in the study;
•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 beer or 45 mL liquor with 40% alcohol or 150 mL wine);

Arms & Interventions

HSK3486

Subjects \< 65 years old:0.4mg/kg/0.15mg/kg;Subjects ≥ 65 years old:75% of the dose for subjects \< 65 years old.

Intervention: HSK3486

Propofol

Subjects \< 65 years old:2mg/kg/0.75mg/kg;Subjects≥ 65 years old:75% of the dose for subjects \< 65 years old.

Intervention: Propofol

Outcomes

Primary Outcomes

Success rate of fiberoptic bronchoscopy. A successful diagnosis/treatment should meet both of the following:

Time Frame: During induction of sedation/anesthetic on day 1

1. Completion of fiberoptic bronchoscopy; 2. No alternative sedation/anesthetic drugs are used, that is, the number of doses of the study drug is ≤ 5 times within any given 15-minute period, starting from the initial administration until the fiberoptic bronchoscopy is completed.

Secondary Outcomes

Time to successful sedation/anesthetic induction(From the initial administration of the investigational drug to the first time when MOAA/S is ≤1 on day 1)
Time to fully awake(From the last dose of study drug or rescue sedative AND from end of fiberoptic bronchoscopy until the patient has recovered to fully alert on day 1)
Time to discharge(Time from the last dose of study drug or rescue sedative and from the end of fiberoptic bronchoscopy until discharge (defined as the ability to walk unassisted) on day 1)
Use of questionnaires to estimate sedation/anesthesia satisfaction, including satisfaction assessments of the subject and anesthesiologist(During induction of sedation/anesthetic on day 1)
Use of the investigational drug and alternative drugs(During induction of sedation/anesthetic on day 1)