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NCT Number: NCT03921775

A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery

The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate compared to propofol for general anesthesia during elective surgery.

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Key information

Conditions

Anesthesia for Elective Surgery Patients

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

Who can participate

Healthy volunteers accepted: No

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

Inclution Criteria:

  • 18~60 years, female or male
  • Patients scheduled for an elective surgical procedure(mechanical ventilation via endotracheal tube)
  • BMI: 18~30 kg/m2
  • Patients understand clearly and participate in the study voluntarily, and sign the informed consent

Exclusion criteria

  • Patients scheduled for emergency surgery
  • Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
  • One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.)
  • Pregnant women or those in lactation period
  • Allergic to drugs used in the study
  • Patients with respiratory management difficulties (Modified Mallampati grade IV)
  • Patients have participated in other clinical trial within the 3 months prior to randomization
  • Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason

Treatment and study plan

Remimazolam Tosilate

Drug

For induction and maintenance of general anesthesia

Propofol

Drug

For induction and maintenance of general anesthesia

Primary outcomes

  1. Percentage(%) of paticipants who experienced successful anesthesia during operation in each group

    Time frame: Average of 2 hours

Secondary outcomes

  1. Time from start of investigational medicinal product administration to loss of consciousness

    Time frame: Average of 2 hours

  2. Time from stop of investigational medicinal product to MOAA/S Score=5

    Time frame: Average of 2 hours

  3. Time from stop of investigational medicinal product to Aldrete Score>9

    Time frame: Average of 2 hours

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Single-blind, Parallel and Control Phase III Trial Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2019
Registry last updated
May 15, 2020

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.

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