Clinical trial NCT03698617: A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486
Official title: A Phase IIa, Open-label, Propofol-controlled ,Dose-escalation, Multi-center Study to Evaluate the Tolerance, Efficacy and Safety of HSK3486 for Induction of General Anesthesia in Elective Surgery Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Induction of General Anaesthesia
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is consisted of two cohorts, dose-escalation and dose-expansion cohorts. The doses in dose- expansion cohort were selected from dose-escalation results.


Eligibility criteria: Inclusion Criteria:

1. Inpatients required tracheal intubation under general anesthesia and a non-emergency non-cardiothoracic and non-extracranial elective surgery for an estimated duration of ≤ 3 h ;.
2. Males or females, aged ≥ 18 and ≤ 65 years old;
3. Body mass index (BMI) ≥ 19 and ≤ 30 kg/m2;
4. ASA grade I\~II;
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 were contraindicated in general anesthesia.;
2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated
3. Patients in receipt of any investigational drug within 30 days before screening.
4. Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within one month prior to the screening period.
5. Patients in receipt of general anesthesia surgery within two weeks prior to the screening period.
6. The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, liver, kidney, blood system, or metabolic system disease prior to the screening period.
7. Abnormal laboratory results consisting of any of the following: :

1) AST and ALT≥ 2×ULN； 2）TBIL≥ 1.5×ULN； 3）Hb≤ 90g/L; 4）ANC≤1.5×109/L; 5) PLT≤80×109/L； 6） serum creatinine≥ 1.5×ULN.

8. Patients with a history of drug or ethanol abuse with the past 3 months. 9. Pregnant women or female patients with a positive serum or urine human chorionic gonadotropin pregnancy test at screening or baseline or lactating female patients. . 10. 10. Patients with a positive Allen 's test who collected arterial blood for PK study.

11. Patients with respiratory management difficulties. 12. Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).

Primary outcomes:
measure: The success rate of induction of general anesthesia
timeFrame: during induction of general anesthesia on day 1
Secondary outcomes:
measure: Time from start of IMP administration to loss of eyelash reflex
timeFrame: during induction of general anesthesia on day 1
measure: Time from start of IMP administration to loss of consciousness
timeFrame: during induction of general anesthesia on day 1
measure: Time from start of IMP administration to intubation and the intubation reaction
timeFrame: during induction of general anesthesia on day 1
measure: Mini-Mental State Examination (MMSE) total scores(0-30) by time point
timeFrame: Pre-dose to 48 hours post-dose
measure: change from baseline in blood pressure （systolic, diastolic and mean arterial pressure)
timeFrame: pre-dose to 20 minutes post-dose
measure: change from baseline in heart rate
timeFrame: pre-dose to 20 minutes post-dose
measure: change from baseline in arterial oxygen saturation
timeFrame: pre-dose to 20 minutes post-dose
measure: Number of patients with adverse events
timeFrame: Pre-dose to 48 hours post-dose
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The 2nd Affiliated Hospital of WMU
state: Zhejiang
Study officials:
References: