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NCT Number: NCT04908553

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

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.

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Key information

Conditions

Hypotension During Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

TongjiHospital

Wuhan, China

About this study

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

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Remimazolam Tosilate for Injection 0.1mg/kg

Drug

Remimazolam Tosilate for Injection 0.1mg/kg at induction

Other names: low dose group

Remimazolam Tosilate for Injection 0.15mg/kg

Drug

Remimazolam Tosilate for Injection 0.15mg/kg at induction

Other names: medium dose group

Remimazolam Tosilate for Injection 0.2mg/kg

Drug

Remimazolam Tosilate for Injection 0.2mg/kg at induction

Other names: high dose group

Primary outcomes

  1. Incidence of hypotension during the anesthesia

    Time frame: during the anesthesia procedure

    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

  2. The rate of Successful sedation during the anesthesia

    Time frame: during the anesthesia procedure

    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.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2021
Registry last updated
Jun 29, 2025

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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