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Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy

NCT05406102 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-07-01

No results posted yet for this study

Summary

Gastroenteroscopy diagnosis and treatment drugs need to meet the needs of quick onset, quick recovery and less anesthesia complications. Remimazolam is an anesthetic sedative independently developed by China. It is a new short-acting GABA(A) receptor agonist. Remimazolam has the advantages of rapid onset, rapid recovery, antagonist, controllable degree of cardiovascular and respiratory depression, low incidence of hypotension and respiratory depression. However, elderly patients as important and special patients, there are still a lack of relevant studies and reports.

In order to verify the safety and effectiveness of remimazolam in the gastroenteroscopy treatment of elderly patients, it can reduce the incidence of intraoperative hypotension or respiratory depression rate, improve the quality of recovery of elderly patients.

Conditions

  • Anesthetics
  • Recovery
  • Drug Effect
  • Safety
  • Psychotropic Drugs
  • Anesthetics, Intravenous

Interventions

DRUG

Remimazolam

Patients received an initial dose of 0.1mg/kg of remimazolam (add to 0.05 mg/kg top-ups doses to a total of up to five times within 15minutes).

DRUG

Propofol group

Patients received an initial dose of 1.5mg/kg of propofol(add to 0.5 mg/kg top-ups doses to a total of up to five times within 15minutes).

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Qiang Wang · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-10
Primary Completion
2023-05-01
Completion
2023-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406102 on ClinicalTrials.gov