Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05801757

Enrollment

114

Registered

2023-04-06

Start date

2023-05-01

Completion date

2024-04-30

Last updated

2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Disease

Keywords

colonoscopic polypectomy, elderly patients

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.

Interventions

DRUGRemimazolam

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

DRUGPropofol

propofol 2-3mg/kg/h

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Single blind

Intervention model description

Single blind, prospective, randomized controlled study

Eligibility

Sex/Gender

ALL

Age

60 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Sedation success rate	1 day	Evaluating the success rate of sedation using the modified MOAA/S scoring table

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026