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NCT05557253 Clinical Trial

Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

Intraoperative Hypotension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05557253
Other study ID # Bypass-RMDZ
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2022
Est. completion date December 30, 2023

Study information
Verified date October 2022
Source Seoul National University Hospital
Contact Chang-Hoon Koo
Phone +821085098841
Email vollock9@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 72
Est. completion date December 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Remimazolam
Anesthesia induction: remimazolam 6-12 mg/kg/h Anesthesia maintenance: remimazolam 1-2 mg/kg/h
• Balanced Anesthesia
Anesthesia induction: propofol 1.5-2 mg/kg Anesthesia maintenance: Desflurane 6-8 vol%

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative hypotension Target Systolic Blood Pressure < 80% During surgery
Secondary Inotropic requirements Dose of inotropics administered during surgery During surgery
Secondary Incidence of bradycardia heart rate < 40 /min During surgery
Secondary Incidence of tachycardia heart rate > 100 /min During surgery
Secondary Maximum systolic blood pressure Maximal systolic blood pressure during surgery (mmHg) During surgery
Secondary Minimum systolic blood pressure Minimal systolic blood pressure during surgery (mmHg) During surgery
Secondary Brain relaxation score 1=perfectly relaxed, 2=satisfactorily relaxed, 3=firm brain, 4=bulging brain Immediately after dura opening
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