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Completed

NCT Number: NCT03709056

A Study Evaluating the Efficacy and Safety of HSK3486

A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital, Sichuan University, Changde, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled to undergo a diagnostic or therapeutic colonoscopy;
  • Male or female patients, ASA grade I~III, aged ≥ 18 and≤ 70;
  • Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
  • the respiratory rate ≥10 and ≤24, SpO2 when inhaling ≥95%, SBP≥90mmHg, DBP≥60mmHg, HR≥55and ≤100;
  • 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

  • Patients were contraindicated in general anesthesia.
  • Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated.
  • 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.
  • Patients with a history of drug or ethanol abuse with the past 3 months.
  • Patients with respiratory management difficulties.
  • Patients in receipt of any investigational drug within 30 days before screening.
  • Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within 72 hours before screening.
  • Abnormal laboratory results consisting of any of the following:
  • neutrophil count≤ 1.5×109/L; 2)platelet≤ 80×109/L; 3)hemoglobin≤ 90 g/L; 4)aspartate aminotransferase≥ 1.5×ULN; 5) 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.
  • Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason)

Treatment and study plan

HSK3486

Drug

HSK3486 intravenous (iv) 0.4(0.5) mg/kg for induction, and 0.2 (0.15)mg/kg top-ups for maintenance. 0.3(0.375) mg/kg for induction and 0.15 (0.113)mg/kg for maintenance in adults of 65-70 years old

Propofol

Drug

Propofol iv 2.0 mg/kg for induction, and 1.0 mg/kg top-ups for maintenance. 1.5 mg/kg for induction and 0.75mg/kg for maintenance in adults of 65-70 years old.

Primary outcomes

  1. Success of colonoscopy procedure

    Time frame: from the first dose of the study drug to removal of colonoscope on day 1

    Measured by completion of colonoscopy, no requirement for an alternative sedative or anesthesia drug and no requirement for more than 5 doses of study drug within any 15 minute period.

Secondary outcomes

  1. Time to start of procedure

    Time frame: From first dose of study drug until insertion of colonoscope on day 1

  2. The success rate of the colonoscopy procedure

    Time frame: from the first dose of the study drug to removal of colonoscope on day 1

    The number of patients who successfully completed the colonoscopy procedure accounted for the proportion of all patients in the dose group

  3. Time to fully alert

    Time frame: from the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1

  4. Time to discharge

    Time frame: from the removal of colonoscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1

  5. Application of study drug and alternative medication

    Time frame: during the colonoscopy procedure on day 1

    total dosages of study drug and alternative medication

Sponsors and collaborators

Lead sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd

Industry

Registry information

Official study title

A Phase IIb, Randomized, Double-blind, Propofol-controlled, Multi-center Study Evaluating the Efficacy and Safety of HSK3486 for Sedation and Anesthesia in Patients Undergoing Diagnostic Colonoscopy.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2018
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.