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Completed

NCT Number: NCT05015361

A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation

To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able and willing to provide a written informed consent
  • Subjects requiring local anesthesia assisted sedation
  • Male or female
  • Meet the weight standard
  • Conform to the ASA Physical Status Classification

Exclusion criteria

  • Previous respiratory or pulmonary diseases
  • Subjects who had received general anesthesia
  • Subjects with a history of myocardial infarction or unstable angina pectoris
  • Subjects with atrioventricular block or cardiac insufficiency
  • Subjects with a history of ischemic stroke or transient ischemic attack
  • Subjects with poor blood pressure control after medication
  • Subjects with abnormal clotting function
  • Subjects with a history of mental illness and a history of cognitive impairment epilepsy
  • Subjects with a history or possibility of a difficult airway
  • Subject with a history of substance abuse and drug abuse
  • Abnormal values in the laboratory
  • Allergic to a drug ingredient or component
  • Pregnant or nursing women
  • No birth control during the specified period of time
  • Participated in clinical trials of other drugs (received experimental drugs)
  • The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Treatment and study plan

Remimazolam Tosilate

Drug

Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose

Propofol Injection.

Drug

Treatment group C: Propofol Injection.

Primary outcomes

  1. The time to maintain target sedation as a percentage of the total study administration time.

    Time frame: through study completion,an average of about 1 hour

Secondary outcomes

  1. Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs;

    Time frame: 3 minutes after administration

  2. Proportion of subjects receiving remedial sedation;

    Time frame: through study completion,an average of about 1 hour

  3. The time from the start of intravenous injection of load dose test drug to the first achievement of target sedation;

    Time frame: Time to achieve target sedation, an average of about 4 minutes

  4. The time from stopping infusion of test drugs to reaching MOAA/S level 5 for the first time after operation

    Time frame: Recovery time, an average of about 7 minutes

  5. Anesthesiologists' satisfaction with sedation

    Time frame: through study completion,an average of about 1 hour

  6. Evaluation of subjects' satisfaction with sedation treatment;

    Time frame: through study completion,an average of about 1 hour

  7. Incidence of anterograde amnesia.

    Time frame: through study completion,an average of about 1 hour

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation -- a Multicenter, Randomized, Single Blind, Positive Drug Parallel Controlled Phase II Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2021
Registry last updated
Aug 20, 2021

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.