Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients

September 4, 2023 updated by: aijun xu, Tongji Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Study Chair: aihua Du, Dr., Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

March 26, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

You can request it from the main researcher

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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