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Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients

NCT07002801 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-06-04

No results posted yet for this study

Summary

The objective of this clinical trial is to assess the feasibility of the remimazolam combined with esketamine OFA (opioid-free anesthesia) protocol for painless gastroscopy and colonoscopy in elderly patients and to determine if it is non-inferior to the traditional OA (opioid-containing anesthesia) protocol. The main questions it aims to answer are:

* Is the remimazolam combined with esketamine protocol feasible for painless gastroscopy and colonoscopy in elderly patients?
* Is the OFA protocol superior to the OA protocol?

Participants will:

* During anesthesia induction, the experimental group will receive remimazolam combined with esketamine for anesthesia, while the control group will receive remimazolam combined with remifentanil.
* Record respiratory and circulatory indicators and adverse reaction times.

Conditions

  • Gastrointestinal Disease

Interventions

COMBINATION_PRODUCT

remimazolam-remifentanil

For elderly patients scheduled for elective painless gastro-intestinal endoscopy, remimazolam 0.2mg/kg and remifentanil 0.2ug/kg are used for anesthesia induction. During the operation, the doses are adjusted according to the depth of sedation of the patients.

COMBINATION_PRODUCT

remimazolam-esketamine

For elderly patients scheduled for painless gastroenterological endoscopy, remimazolam 0.2mg/kg and esketamine 0.15mg/kg are used for anesthesia induction. During the operation, the dosage is adjusted according to the patient's level of sedation.

Sponsors & Collaborators

  • First Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • Harbin Medical University

    lead OTHER

Principal Investigators

  • SHI Jinghui SHI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2026-06-30
Completion
2028-01-31

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 NCT07002801 on ClinicalTrials.gov