Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients

Not Applicable

Completed

• Conditions: Colon Disease
• Interventions: Drug: Remimazolam; Drug: Propofol

• Registration Number: NCT05801757
• Lead Sponsor: Tongji Hospital

Brief Summary

To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy.

Detailed Description

To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy, and to screen the optimal dose of remidazolam, in order to provide a more reasonable and safe sedative and analgesic drug regimen for elderly outpatients undergoing colonoscopic polypectomy.

Study Timeline

• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-06
• Study Start: 2023-05-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Age 60-80 years old;
• ASA Level I - III;
• Operation time: 15min~1h;
• BMI18.0-29.9；

Exclusion Criteria

• Emergency surgery;
• Patients with high risk of gastric satiety and reflux aspiration;
• Allergies to benzodiazepines and opioids;
• Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
• Abnormal liver and kidney function;
• Previous drug use history;
• Recently participated in other clinical studies;
• Patients who cannot cooperate with communication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R2 group	Remimazolam	remimazolam 0.75mg/kg/h
Propofol group	Propofol	propofol 2-3mg/kg/h
R1 group	Remimazolam	remimazolam 0.5mg/kg/h

Primary Outcome Measures

Name	Time	Method
Sedation success rate	1 day	Evaluating the success rate of sedation using the modified MOAA/S scoring table

Secondary Outcome Measures

Name	Time	Method
Intraoperative time record	Intraoperative	Anesthesia time; Operation time; Wake up time; PACU time
Drug usage	1 day	doses of propofol,remimazolam and other drugs used
The incidence of adverse reactions during surgery	1 day	includes: body movements, hypoxemia, hypotension, bradycardia; Intraoperative awareness
Incidence of postoperative adverse reactions	24 hours after surgery	Postoperative nausea and vomiting, postoperative pain, hypotension, bradycardia, dizziness

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China