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

Hypotension During Surgery Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908553
• Other study ID #: 2021S027
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2023
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: January 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. ASA ?-? 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

Related Conditions & MeSH terms

• Hypotension
• Hypotension During Surgery

Intervention

Drug:
• Remimazolam Tosilate for Injection 0.1mg/kg
Remimazolam Tosilate for Injection 0.1mg/kg at induction
• Remimazolam Tosilate for Injection 0.15mg/kg
Remimazolam Tosilate for Injection 0.15mg/kg at induction
• Remimazolam Tosilate for Injection 0.2mg/kg
Remimazolam Tosilate for Injection 0.2mg/kg at induction

Locations

Country	Name	City	State
China	TongjiHospital	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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