Sedation or Anesthesia
Conditions
Keywords
Sedation anesthesia fiberoptic bronchoscopy
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.
Interventions
DRUGHSK3486
Subjects \< 65 years old:Initial dose of 0.4 mg/kg followed by 0.15 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects \< 65 years old.
DRUGPropofol
Subjects \< 65 years old:Initial dose of 2 mg/kg followed by 0.75 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects \< 65 years old.
Sponsors
Sichuan Haisco Pharmaceutical Group Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
1. Patients with contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents; 2. Patient known to be allergic to eggs, soy products, opioids and their antidotes, and propofol; patient having contraindications to propofol, opioids and their antidotes; 3. Patients who have undergone endotracheal intubation and/or mechanical ventilation prior to diagnostic or therapeutic bronchoscopy; 4. Medical history or evidence of any of the following prior to screening/at baseline, which may increase sedation/anesthesia risk: 1. 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 \[during screening only (corrected using Fredericia's formula1)\]; 2. 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; 3. 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; 4. History of gastrointestinal diseases: gastrointestinal retention, active hemorrhage, or history of gastroesophageal reflux or obstruction that may lead to aspiration; 5. 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; 6. 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); 7. History of drug abuse within 3 months prior to screening; 8. History of blood transfusion within 14 days prior to screening; 5. Patients with the following respiratory risks during screening/at baseline: 1. Acute asthma attack; 2. Sleep apnea syndrome; 3. History of malignant hyperthermia or family history; 4. History of failed tracheal intubation; 5. Difficult airway (modified Mallampati score ≥ III) as determined by the investigator; 6. Patient who received any of the following medications or treatments during screening/at baseline: 1. Received any investigational drug within 1 month prior to screening; 2. Received propofol, other sedatives/anesthetics, and/or opioid analgesics or compounds containing analgesics within 72 h prior to baseline; 7. Laboratory results meeting any of the following criteria during screening/at baseline, confirmed by re-examination: 1. WBC ≤ 3.0 × 10\^9/L; 2. Platelets ≤ 80 × 10\^9/L; 3. Hemoglobin ≤ 80 g/L; 4. Prothrombin time ≥ 1.5 × ULN; 5. Activated partial thromboplastin time (aPTT) ≥ 1.5 × ULN; 6. ALT and/or AST ≥ 3 × ULN; 7. Total bilirubin ≥ 1.5 × ULN; 8. Serum creatinine ≥ 1.5 × ULN. 8. 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); 9. Subject judged by the investigator to have any other factors unsuitable for involvement in the study. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of fiberoptic bronchoscopy. A successful diagnosis/treatment should meet both of the following: | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | the time from the withdrawal of the bronchoscope or the last dose of the study drug to the first of 3 consecutive MOAA/S scores = 5 |
| 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 | the time from the withdrawal of the bronchoscope or the last dose of the study drug to the first of 3 consecutive Aldrete scores ≥ 9 |
| Use of the investigational drug and alternative drugs | During induction of sedation/anesthetic 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 | — |
Countries
China
Outcome results
None listed