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Clinical Trials/NCT05557253
NCT05557253
Recruiting
Not Applicable

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

Seoul National University Hospital1 site in 1 country72 target enrollmentOctober 20, 2022
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ConditionsIntraoperative Hypotension
InterventionsRemimazolamBalanced Anesthesia
DrugsRemimazolamBalanced Anesthesia

Overview

Phase
Not Applicable
Intervention
Remimazolam
Conditions
Intraoperative Hypotension
Sponsor
Seoul National University Hospital
Enrollment
72
Locations
1
Primary Endpoint
Intraoperative hypotension
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2022
End Date
December 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chang-Hoon Koo

Assistant professor

Seoul National University Hospital

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
  • •Acute narrow-angle glaucoma
  • •Shock or Coma
  • •Acute alcohol addicted
  • •Obstructive sleep apnea
  • •dependency on alcohol or drug
  • •Severe acute respiratory insufficiency

Arms & Interventions

remimazolam group

General anesthesia is induced and maintained with remimazolam.

Intervention: Remimazolam

balanced group

General anesthesia is induced with propofol and maintained with desflurane.

Intervention: Balanced Anesthesia

Outcomes

Primary Outcomes

Intraoperative hypotension

Time Frame: During surgery

Target Systolic Blood Pressure \< 80%

Secondary Outcomes

  • 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)
  • Brain relaxation score(Immediately after dura opening)

Study Sites (1)

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