search
Back to results

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

Primary Purpose

Hypotension During Surgery

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Remimazolam Tosilate for Injection 0.1mg/kg
Remimazolam Tosilate for Injection 0.15mg/kg
Remimazolam Tosilate for Injection 0.2mg/kg
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypotension During Surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TongjiHospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

low dose group

medium dose group

high dose group

Arm Description

Remimazolam Tosilate for Injection 0.1mg/kg at induction

Remimazolam Tosilate for Injection 0.15mg/kg at induction

Remimazolam Tosilate for Injection 0.2mg/kg at induction

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2021
Last Updated
April 11, 2023
Sponsor
Tongji Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04908553
Brief Title
Study on the Safety and Effectiveness of Remimazolam Tosilate for Injection for Short-term Elective Surgery in Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension During Surgery

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low dose group
Arm Type
Other
Arm Description
Remimazolam Tosilate for Injection 0.1mg/kg at induction
Arm Title
medium dose group
Arm Type
Other
Arm Description
Remimazolam Tosilate for Injection 0.15mg/kg at induction
Arm Title
high dose group
Arm Type
Other
Arm Description
Remimazolam Tosilate for Injection 0.2mg/kg at induction
Intervention Type
Drug
Intervention Name(s)
Remimazolam Tosilate for Injection 0.1mg/kg
Other Intervention Name(s)
low dose group
Intervention Description
Remimazolam Tosilate for Injection 0.1mg/kg at induction
Intervention Type
Drug
Intervention Name(s)
Remimazolam Tosilate for Injection 0.15mg/kg
Other Intervention Name(s)
medium dose group
Intervention Description
Remimazolam Tosilate for Injection 0.15mg/kg at induction
Intervention Type
Drug
Intervention Name(s)
Remimazolam Tosilate for Injection 0.2mg/kg
Other Intervention Name(s)
high dose group
Intervention Description
Remimazolam Tosilate for Injection 0.2mg/kg at induction
Primary Outcome Measure Information:
Title
Incidence of hypotension during the anesthesia
Description
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
Time Frame
during the anesthesia procedure
Title
The rate of Successful sedation during the anesthesia
Description
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.
Time Frame
during the anesthesia procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ailin Luo, Doctor
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
TongjiHospital
City
Wuhan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs