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Completed

NCT Number: NCT04400201

A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy

A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.

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Key information

Conditions

Sedation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18~80 years, female or male
  • Patients scheduled for an bronchoscopy procedure
  • 18 kg/m2<BMI<30kg/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 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

Intravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance.

Propofol

Drug

Intravenous injection at a dose of 1.5~2.5mg/kg for sedation induction and continuous intravenous infusion at the dose of 0~12 mg/kg/h for sedation maintenance

Primary outcomes

  1. Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group

    Time frame: From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment

Secondary outcomes

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

    Time frame: From the onset of administration of the study drug to unconsciousness on Day 1 of treatment

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

    Time frame: From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment

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

    Time frame: From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 22, 2020
Registry last updated
Aug 22, 2022

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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