Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

October 25, 2022 updated by: Chang-Hoon Koo, Seoul National University Hospital

Effects of Remimazolam on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial

This study is a randomized, controlled trial. A total of 72 patients will be randomized to receive remimazolam anesthesia or balanced anesthesia (propofol + desflurane) during extracranial-intracranial bypass surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

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

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

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

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who undergo elective extracranial-intracranial bypass surgery
  • American Society of Anesthesiologists grade 1,2,3
  • Age > 18 years old

Exclusion Criteria:

  • Refuse to participate to the study
  • American Society of Anesthesiologists grade 4
  • Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
  • Allergic history of benzodiazepine
  • Pregnant
  • Acute narrow-angle glaucoma
  • Shock or Coma
  • Acute alcohol addicted
  • Obstructive sleep apnea
  • dependency on alcohol or drug
  • Severe acute respiratory insufficiency
  • Hypersensitivity to Dextran 40

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: remimazolam group
General anesthesia is induced and maintained with remimazolam.
Drug: Remimazolam
Anesthesia induction: remimazolam 6-12 mg/kg/h Anesthesia maintenance: remimazolam 1-2 mg/kg/h
Active Comparator: balanced group
General anesthesia is induced with propofol and maintained with desflurane.
Drug: Balanced Anesthesia
Anesthesia induction: propofol 1.5-2 mg/kg Anesthesia maintenance: Desflurane 6-8 vol%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative hypotension
Time Frame: During surgery
Target Systolic Blood Pressure < 80%
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inotropic requirements
Time Frame: During surgery
Dose of inotropics administered during surgery
During surgery
Incidence of bradycardia
Time Frame: During surgery
heart rate < 40 /min
During surgery
Incidence of tachycardia
Time Frame: During surgery
heart rate > 100 /min
During surgery
Maximum systolic blood pressure
Time Frame: During surgery
Maximal systolic blood pressure during surgery (mmHg)
During surgery
Minimum systolic blood pressure
Time Frame: During surgery
Minimal systolic blood pressure during surgery (mmHg)
During surgery
Brain relaxation score
Time Frame: Immediately after dura opening
1=perfectly relaxed, 2=satisfactorily relaxed, 3=firm brain, 4=bulging brain
Immediately after dura opening

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Chang-Hoon Koo, Seoul National University Bundang 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)

October 20, 2022

Primary Completion (Anticipated)

October 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

September 25, 2022

First Submitted That Met QC Criteria

September 25, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bypass-RMDZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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