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Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05557253
Enrollment
72
Registered
2022-09-27
Start date
2022-10-20
Completion date
2023-12-30
Last updated
2022-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Hypotension

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.

Interventions

DRUGBalanced Anesthesia

Anesthesia induction: propofol 1.5-2 mg/kg Anesthesia maintenance: Desflurane 6-8 vol%

DRUGRemimazolam

Anesthesia induction: remimazolam 6-12 mg/kg/h Anesthesia maintenance: remimazolam 1-2 mg/kg/h

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative hypotensionDuring surgeryTarget Systolic Blood Pressure \< 80%

Secondary

MeasureTime frameDescription
Incidence of bradycardiaDuring surgeryheart rate \< 40 /min
Incidence of tachycardiaDuring surgeryheart rate \> 100 /min
Inotropic requirementsDuring surgeryDose of inotropics administered during surgery
Minimum systolic blood pressureDuring surgeryMinimal systolic blood pressure during surgery (mmHg)
Brain relaxation scoreImmediately after dura opening1=perfectly relaxed, 2=satisfactorily relaxed, 3=firm brain, 4=bulging brain
Maximum systolic blood pressureDuring surgeryMaximal systolic blood pressure during surgery (mmHg)

Countries

South Korea

Contacts

Primary ContactChang-Hoon Koo
vollock9@gmail.com+821085098841

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026