Body Composition Analysis and Time to Emergence From Remimazolam

January 2, 2023 updated by: Jong Hwan Lee, Samsung Medical Center

Value of Body Composition Analysis in Predicting Delayed Emergence From Remimazolam-based General Anesthesia: A Prospective Observational Study.

Remimazolam is a novel general anesthetic drug. The time to emergence from remimazolam-based general anesthesia is variable among patients, but little is known about the risk factors for delayed emergence. We believe that information from body composition analysis may be helpful in understanding which patients are more likely to show delayed emergence from remimazolam.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center, Sungkyunkwan University, School of Medicine

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult ASA I-III patients undergoing cerebral aneurysm coil embolization under general anesthesia using remimazolam

Description

Inclusion Criteria:

  • Adult ASA I-III patients undergoing cerebral aneurysm coil embolization under general anesthesia using remimazolam

Exclusion Criteria:

  • Patients with preoperative mental change, hemodynamic instability, hemodialysis, heart failure, hypoalbuminemia, pregnancy

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
remimazolam
general anesthesia induction with 6mg/kg/hr continuous infusion of remimazolam. general anesthesia maintenance with 1mg/kg/hr continuous infusion of remimazolam.
Device: body composition analysis
Body composition analysis by bioelectrical impedance measurement, just before induction of anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
emergence time
Time Frame: at the time of emergence
relationship between body composition analysis information and time to emergence after discontinuing remimazolam infusion.
at the time of emergence

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to loss of consciousness
Time Frame: at the time of induction
relationship between body composition analysis information and time to loss of consciousness after starting remimazolam infusion.
at the time of induction
hypotension
Time Frame: from induction to emergence of anesthesia
relationship between body composition analysis information and hypotensive event during anesthesia
from induction to emergence of anesthesia

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

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)

September 5, 2022

Primary Completion (Actual)

December 30, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

August 21, 2022

First Submitted That Met QC Criteria

August 21, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SMC 2022-06-074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Clinical Trials on Body Composition

Clinical Trials on body composition analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe