NCT05041725

Brief Summary

This study analyzes the impact of intraoperative Remimazolam infusion for postoperative sedation on the left ventricular global longitude strain (LV-GLS) patients undergoing cardiac surgery

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_4 coronary-artery-disease

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

August 31, 2021

Last Update Submit

September 8, 2021

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • change of the left ventricular global longitudinal strain

    mean values of the left ventricular global longitudinal strain after 3 minutes, 5 minutes and 10 minutes after the Remimazolam administration

    1 minutes

Study Arms (1)

remimazolam infusion

EXPERIMENTAL

Intraoperative remimazolam infusion for postoperative sedation

Drug: Remimazolam Injection [Byfavo]

Interventions

Remimazolam Injection [Byfavo]DRUG

Remimazolam injection and continuous infusion for postoperative sedation, 0.2 mg/kg for 1 min and continuous infusion of 1-2 mg/kg/hour

Also known as: Remimazolam infusion
remimazolam infusion

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective off-pump coronary artery bypass surgery

You may not qualify if:

  • arrhythmia
  • LV ejection fraction \< 50 %
  • preoperative inotropic support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

remimazolam

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Anesthesiology

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 13, 2021

Study Start

November 1, 2021

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share