Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients

Study Overview
=================
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.

Official Title
-----------------
Sedative Effect of Remidazolam Besylate Continuous Pump Infusion for Colonoscopic Polypectomy in Elderly Patients

Conditions
-----------------
Colon Disease

Intervention / Treatment
-----------------
* Drug: Remimazolam
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blind, prospective, randomized controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol group<br>propofol 2-3mg/kg/h | Drug: Propofol<br>* propofol 2-3mg/kg/h<br>* Other names: Diprivan;|
| Experimental: R1 group<br>remimazolam 0.5mg/kg/h | Drug: Remimazolam<br>* Using two different doses of remidazolam for continuous pumping to maintain anesthetic effect<br>* Other names: Remimazolam besylate;|
| Experimental: R2 group<br>remimazolam 0.75mg/kg/h | Drug: Remimazolam<br>* Using two different doses of remidazolam for continuous pumping to maintain anesthetic effect<br>* Other names: Remimazolam besylate;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation success rate | Evaluating the success rate of sedation using the modified MOAA/S scoring table | 1 day | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopic polypectomy, elderly patients