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

NCT04908553 | Completed Phase 4

• 1 other identifier: 2021S027
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypotension During Surgery

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

low dose group

OTHER

Remimazolam Tosilate for Injection 0.1mg/kg at induction

Drug: Remimazolam Tosilate for Injection 0.1mg/kg

medium dose group

OTHER

Remimazolam Tosilate for Injection 0.15mg/kg at induction

Drug: Remimazolam Tosilate for Injection 0.15mg/kg

high dose group

OTHER

Remimazolam Tosilate for Injection 0.2mg/kg at induction

Drug: Remimazolam Tosilate for Injection 0.2mg/kg

Interventions

Remimazolam Tosilate for Injection 0.1mg/kg DRUG

Remimazolam Tosilate for Injection 0.1mg/kg at induction

Also known as: low dose group

low dose group

Remimazolam Tosilate for Injection 0.15mg/kg DRUG

Remimazolam Tosilate for Injection 0.15mg/kg at induction

Also known as: medium dose group

medium dose group

Remimazolam Tosilate for Injection 0.2mg/kg DRUG

Remimazolam Tosilate for Injection 0.2mg/kg at induction

Also known as: high dose group

high dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Ⅰ-Ⅲ grade;
• age 18-65 years old;
• gender is not limited;
• 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;
• operation time No more than 90min.

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

TongjiHospital

Wuhan, China

Location

MeSH Terms

Interventions

Injections; Population Groups

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Demography; Population Characteristics

Study Officials

• Ailin Luo, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, professor

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 1, 2021
• Study Start: July 1, 2021
• Primary Completion: March 30, 2025
• Study Completion: May 31, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)