Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
1 active site
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
September 25, 2022
CompletedFirst Posted
Study publicly available on registry
September 27, 2022
CompletedStudy Start
First participant enrolled
October 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedOctober 27, 2022
October 1, 2022
1 year
September 25, 2022
October 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Intraoperative hypotension
Target Systolic Blood Pressure \< 80%
During surgery
Secondary Outcomes (6)
Inotropic requirements
During surgery
Incidence of bradycardia
During surgery
Incidence of tachycardia
During surgery
Maximum systolic blood pressure
During surgery
Minimum systolic blood pressure
During surgery
- +1 more secondary outcomes
Study Arms (2)
remimazolam group
EXPERIMENTALGeneral anesthesia is induced and maintained with remimazolam.
balanced group
ACTIVE COMPARATORGeneral anesthesia is induced with propofol and maintained with desflurane.
Interventions
Anesthesia induction: remimazolam 6-12 mg/kg/h Anesthesia maintenance: remimazolam 1-2 mg/kg/h
Anesthesia induction: propofol 1.5-2 mg/kg Anesthesia maintenance: Desflurane 6-8 vol%
Eligibility Criteria
You may qualify if:
- Patients who undergo elective extracranial-intracranial bypass surgery
- American Society of Anesthesiologists grade 1,2,3
- Age \> 18 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chang-Hoon Koo
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
September 25, 2022
First Posted
September 27, 2022
Study Start
October 20, 2022
Primary Completion
October 30, 2023
Study Completion
December 30, 2023
Last Updated
October 27, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share