NCT05512559

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

August 21, 2022

Last Update Submit

January 2, 2023

Conditions

RemimazolamBody Composition

Outcome Measures

Primary Outcomes (1)

  • emergence time

    relationship between body composition analysis information and time to emergence after discontinuing remimazolam infusion.

    at the time of emergence

Secondary Outcomes (2)

  • time to loss of consciousness

    at the time of induction

  • hypotension

    from induction to emergence of anesthesia

Study Arms (1)

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

Interventions

body composition analysisDEVICE

Body composition analysis by bioelectrical impedance measurement, just before induction of anesthesia.

remimazolam

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University, School of Medicine

Seoul, 06351, South Korea

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 21, 2022

First Posted

August 23, 2022

Study Start

September 5, 2022

Primary Completion

December 30, 2022

Study Completion

March 1, 2023

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations

KR(1)