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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03921775

Enrollment

330

Registered

2019-04-19

Start date

2019-05-13

Completion date

2019-12-30

Last updated

2020-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia for Elective Surgery Patients

Brief summary

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

Interventions

DRUGRemimazolam Tosilate

For induction and maintenance of general anesthesia

DRUGPropofol

For induction and maintenance of general anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Inclution Criteria: 1. 18\ 60 years, female or male 2. Patients scheduled for an elective surgical procedure(mechanical ventilation via endotracheal tube) 3. BMI: 18\ 30 kg/m2 4. Patients understand clearly and participate in the study voluntarily, and sign the informed consent

Exclusion criteria

1. Patients scheduled for emergency surgery 2. Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period 3. One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.) 4. Pregnant women or those in lactation period 5. Allergic to drugs used in the study 6. Patients with respiratory management difficulties (Modified Mallampati grade IV) 7. Patients have participated in other clinical trial within the 3 months prior to randomization 8. Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason

Design outcomes

Primary

Measure	Time frame
Percentage(%) of paticipants who experienced successful anesthesia during operation in each group	Average of 2 hours

Secondary

Measure	Time frame
Time from start of investigational medicinal product administration to loss of consciousness	Average of 2 hours
Time from stop of investigational medicinal product to MOAA/S Score=5	Average of 2 hours
Time from stop of investigational medicinal product to Aldrete Score>9	Average of 2 hours

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026