Status:
COMPLETED
A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Subjects Undergoing Fiberoptic Bronchoscopy
Lead Sponsor:
Sichuan Haisco Pharmaceutical Group Co., Ltd
Conditions:
Sedation or Anesthesia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 HSK3...
Eligibility Criteria
Inclusion
- 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.
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Exclusion
- 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);
- History of drug abuse within 3 months prior to screening;
- History of blood transfusion within 14 days prior to screening;
- Patients with the following respiratory risks during screening/at baseline:
- Acute asthma attack;
- Sleep apnea syndrome;
- History of malignant hyperthermia or family history;
- History of failed tracheal intubation;
- Difficult airway (modified Mallampati score ≥ III) as determined by the investigator;
- Patient who received any of the following medications or treatments during screening/at baseline:
- Received any investigational drug within 1 month prior to screening;
- Received propofol, other sedatives/anesthetics, and/or opioid analgesics or compounds containing analgesics within 72 h prior to baseline;
- Laboratory results meeting any of the following criteria during screening/at baseline, confirmed by re-examination:
- WBC ≤ 3.0 × 10\^9/L;
- Platelets ≤ 80 × 10\^9/L;
- Hemoglobin ≤ 80 g/L;
- Prothrombin time ≥ 1.5 × ULN;
- Activated partial thromboplastin time (aPTT) ≥ 1.5 × ULN;
- ALT and/or AST ≥ 3 × ULN;
- Total bilirubin ≥ 1.5 × ULN;
- Serum creatinine ≥ 1.5 × ULN.
- Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; or subjects who are planning pregnancy within 3 month after the completion of the trial (including male subjects);
- Subject judged by the investigator to have any other factors unsuitable for involvement in the study.
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Key Trial Info
Start Date :
December 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2020
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT04111159
Start Date
December 6 2019
End Date
July 27 2020
Last Update
December 17 2020
Active Locations (1)
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1
West China Hospital，Sichuan University
Chengdu, China