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NCT05512559 Clinical Trial

Body Composition Analysis and Time to Emergence From Remimazolam

Body Composition Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05512559
Other study ID # SMC 2022-06-074
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 5, 2022
Est. completion date March 2023

Study information
Verified date January 2023
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 90
Est. completion date March 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• body composition analysis
Body composition analysis by bioelectrical impedance measurement, just before induction of anesthesia.

Locations
Country Name City State
Korea, Republic of Samsung Medical Center, Sungkyunkwan University, School of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary emergence time relationship between body composition analysis information and time to emergence after discontinuing remimazolam infusion. at the time of emergence
Secondary time to loss of consciousness relationship between body composition analysis information and time to loss of consciousness after starting remimazolam infusion. at the time of induction
Secondary hypotension relationship between body composition analysis information and hypotensive event during anesthesia from induction to emergence of anesthesia
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