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Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

Primary Purpose

Intraoperative Hypotension

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remimazolam
Balanced Anesthesia
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Hypotension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

remimazolam group

balanced group

Arm Description

General anesthesia is induced and maintained with remimazolam.

General anesthesia is induced with propofol and maintained with desflurane.

Outcomes

Primary Outcome Measures

Intraoperative hypotension
Target Systolic Blood Pressure < 80%

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2022
Last Updated
October 25, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05557253
Brief Title
Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery
Official Title
Effects of Remimazolam on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
remimazolam group
Arm Type
Experimental
Arm Description
General anesthesia is induced and maintained with remimazolam.
Arm Title
balanced group
Arm Type
Active Comparator
Arm Description
General anesthesia is induced with propofol and maintained with desflurane.
Intervention Type
Drug
Intervention Name(s)
Remimazolam
Intervention Description
Anesthesia induction: remimazolam 6-12 mg/kg/h Anesthesia maintenance: remimazolam 1-2 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
Balanced Anesthesia
Intervention Description
Anesthesia induction: propofol 1.5-2 mg/kg Anesthesia maintenance: Desflurane 6-8 vol%
Primary Outcome Measure Information:
Title
Intraoperative hypotension
Description
Target Systolic Blood Pressure < 80%
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Inotropic requirements
Description
Dose of inotropics administered during surgery
Time Frame
During surgery
Title
Incidence of bradycardia
Description
heart rate < 40 /min
Time Frame
During surgery
Title
Incidence of tachycardia
Description
heart rate > 100 /min
Time Frame
During surgery
Title
Maximum systolic blood pressure
Description
Maximal systolic blood pressure during surgery (mmHg)
Time Frame
During surgery
Title
Minimum systolic blood pressure
Description
Minimal systolic blood pressure during surgery (mmHg)
Time Frame
During surgery
Title
Brain relaxation score
Description
1=perfectly relaxed, 2=satisfactorily relaxed, 3=firm brain, 4=bulging brain
Time Frame
Immediately after dura opening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang-Hoon Koo
Phone
+821085098841
Email
vollock9@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Hoon Koo
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Hoon Koo
Email
vollock9@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

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