Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients

NCT ID: NCT05801757

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Colon Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blind, prospective, randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Single blind

Study Groups

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Propofol group

propofol 2-3mg/kg/h

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

propofol 2-3mg/kg/h

R1 group

remimazolam 0.5mg/kg/h

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Using two different doses of remidazolam for continuous pumping to maintain anesthetic effect

R2 group

remimazolam 0.75mg/kg/h

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Using two different doses of remidazolam for continuous pumping to maintain anesthetic effect

Interventions

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Remimazolam

Using two different doses of remidazolam for continuous pumping to maintain anesthetic effect

Intervention Type DRUG

Propofol

propofol 2-3mg/kg/h

Intervention Type DRUG

Other Intervention Names

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Remimazolam besylate Diprivan

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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aijun xu

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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aihua Du, Dr.

Role: STUDY_CHAIR

Tongji Hospital

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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CIRC

Identifier Type: -

Identifier Source: org_study_id

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