NCT07002801

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Elderly patients undergoing painless gastroenteroscopy were randomly divided into remazolam + esketamine group (RE group) and remazolam + remifentanil group (RR group). In RE group, anesthesia induction was as follows: Remazolam 0.2mg/kg, esketamine 0.15mg/kg, lidocaine 0.5mg/kg, changtonine 0.2mg. RR group: Anesthesia induction: remazolam 0.2mg/kg, remifentanil 0.2μg/kg, lidocaine 0.5mg/kg, Changtonine 0.2mg. Remazolam and esketamine/remifentanil were added during the operation according to the depth of sedation and movement of the patient. The outcome measures included success rate of sedation, incidence of respiratory depression, incidence of hypotension and bradycardia, postoperative recovery time, incidence of adverse reactions, postoperative satisfaction of patients and gastroenteroscopists.

Conditions

• Gastrointestinal Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-14
• Primary completion: 2026-06-01
• Completion: 2028-01-01
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: China