Clinical trial NCT03674008: A Phase III Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia
Official title: A Phase III,Randomized, Double-blind, Propofol-controlled, Parallel-design, Multi-center Study Evaluating The Efficacy and Safety of HSK3486 for Sedation or Anesthesia in Patients Undergoing Colonoscopy and Gastroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedation or Anesthesia
Keywords: Sedation anesthesia gastrointestinal endoscopy
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-17
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase III, randomized, double-blind, propofol-controlled, parallel-design, multi-center study to evaluate the efficacy and safety of HSK3486 for sedation or anesthesia in patients undergoing colonoscopy and gastroscopy.

The study will enroll approximately 280 adults. The maximum study duration is anticipated to be up to nine months.


Eligibility criteria: Inclusion Criteria:

1. Scheduled to undergo a diagnostic or therapeutic colonoscopy or gastroscopy;
2. Male or female patients, ASA grade I\~II, aged ≥ 18 and \< 65;
3. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
4. During screening and baseline, the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥60 and ≤100;
5. Patient can understand the procedure of this study and is willing to comply with study requirements. The patient can sign the ICF voluntarily.

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. The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period.
4. Patients with a history of drug or ethanol abuse with the past 3 months.
5. Patients with respiratory management difficulties (Modified Mallampati grade IV).
6. Patients in receipt of any investigational drug within 30 days before screening.
7. Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within 72 hours prior to baseline.
8. Abnormal laboratory results consisting of any of the following:

1) neutrophil count≤ 1.5×109/L； 2）platelet≤ 80×109/L； 3）hemoglobin≤ 90 g/L; 4）aspartate aminotransferase≥ 1.5×ULN； 5）total bilirubin≥ 1.5×ULN； 6） serum creatinine≥ 1.2×ULN. 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. 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: Success of colonoscopy procedure
timeFrame: from the first dose of the study drug to removal of colonoscope on day 1
Secondary outcomes:
measure: The success rate of the gastroscopy procedure
timeFrame: from the first dose of the study drug to removal of gastroscope on day 1
measure: The success rate of the colonoscopy and gastroscopy procedure
timeFrame: from the first dose of the study drug to rem oval of colonoscope and gastroscope on day 1
measure: Time to induction of sedation or anaesthesia
timeFrame: from the first dose of the study drug to the first MOAA/S scores≤1 on day 1
measure: Time to start of procedure
timeFrame: From first dose of study drug until insertion of colonoscope or gastroscope on day 1
measure: Time to fully alert
timeFrame: from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
measure: Time to discharge
timeFrame: from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1
measure: Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians
timeFrame: from time to fully alert, until time to discharge on day 1
Other outcomes:
Locations:
city: Changde
country: China
facility: West China Hospital, Sichuan University
Study officials:
References: