Study on the Safety and Effectiveness of Remimazolam Tosilate for Injection for Short-term Elective Surgery in Adults

Safety and Dose Exploration of Remimazolam Tosilate for Injection for Induction and Maintenance of General Anesthesia Intubation for Elective Short-term Surgery in Adults: a Multi-center, Randomized, Double-blind Clinical Study

Research objective: To explore the safety and dose exploration of Remimazolam Tosilate for Injection for induction and maintenance of general anesthesia in elective short-term surgery in adults.

Main research indicators:(1)Success rate of sedation during induction and maintenance of general anesthesia with remazolam tosylate;(2)The incidence and severity of hypotension in the induction and maintenance phases Study design: Multi-center, randomized, double-blind clinical study. Subject population: patients undergoing elective short-term surgery. Research data collection period: The subject signs the consent form until discharge or death in the hospital or withdrawal from the research.

Number of research centers/sample size: It is planned to enroll 600 patients from 11 hospitals.

Research process: The researchers will include patients who meet the enrollment criteria and agree to participate in the investigation of the support laryngoscope surgery and minor head and neck surgery patients from the elective surgery patients.

Study Overview

• Status: Completed
• Conditions: Hypotension During Surgery
• Intervention / Treatment: Drug: Remimazolam Tosilate for Injection 0.1mg/kg; Drug: Remimazolam Tosilate for Injection 0.15mg/kg; Drug: Remimazolam Tosilate for Injection 0.2mg/kg

Detailed Description

The data collected in this study is recorded by the researcher in the eCRF, including:

1. Data to be collected during the screening period and before the operation: the basic characteristics of the patient and demographic data;
2. Data to be recorded during and/or postoperatively: main research indicators, secondary indicators and other indicators.

• Study Type: Interventional
• Enrollment (Actual): 650
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Wuhan, China
    • TongjiHospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ASA Ⅰ-Ⅲ grade;
2. age 18-65 years old;
3. gender is not limited;
4. planned elective support laryngoscope surgery (glottic polypectomy under support laryngoscope, epiglottic cyst excision under support laryngoscope, benign laryngeal under support laryngoscope Lesion resection), endoscopic septoplasty, endoscopic tympanoplasty, endoscopic middle ear tube insertion, nasopharyngoplasty, head and neck benign mass resection for general anesthesia intubation patients;
5. operation time No more than 90min.

Exclusion Criteria:

- Emergency surgery;

1. abnormal renal function (urea nitrogen ≥1.5×ULN, blood creatinine greater than the upper limit of normal);
2. abnormal liver function;
3. hypovolemia, shock or coma;
4. suffering from mental illness and long-term use of psychotropic drugs;
5. cognition Dysfunction;
6. those who are allergic to or contraindicated to benzodiazepines and their drug components; pregnant or lactating female patients;
7. have a history of drug dependence;
8. have used other sedatives in the past week;
9. have been a subject within the past 3 months Participated in drug clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: low dose group; Remimazolam Tosilate for Injection 0.1mg/kg at induction	Drug: Remimazolam Tosilate for Injection 0.1mg/kg; Remimazolam Tosilate for Injection 0.1mg/kg at induction; Other Names: low dose group
Other: medium dose group; Remimazolam Tosilate for Injection 0.15mg/kg at induction	Drug: Remimazolam Tosilate for Injection 0.15mg/kg; Remimazolam Tosilate for Injection 0.15mg/kg at induction; Other Names: medium dose group
Other: high dose group; Remimazolam Tosilate for Injection 0.2mg/kg at induction	Drug: Remimazolam Tosilate for Injection 0.2mg/kg; Remimazolam Tosilate for Injection 0.2mg/kg at induction; Other Names: high dose group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension during the anesthesia	The systolic blood pressure during the anesthesia is ≤ 90 mmHg, or a reduction of >20% from the baseline period, or the average blood pressure is <65 mmHg	during the anesthesia procedure
The rate of Successful sedation during the anesthesia	Successful sedation during the anesthesia is defined as: 1) successful induction of anesthesia without anesthesia remedial measures during the induction period; 2) no recovery during the anesthesia maintenance period, no unexpected physical activity, and no remedial measures during the maintenance period anesthesia.	during the anesthesia procedure

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Ailin Luo, Doctor, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): March 30, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: 2021S027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No