Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

Not Applicable

Recruiting

• Conditions: Intraoperative Hypotension
• Interventions: Drug: Balanced Anesthesia; Drug: Remimazolam

• Registration Number: NCT05557253
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-09-25
• Study First Posted: 2022-09-27
• Status Verified: 2022-10
• Study Start: 2022-10-20
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balanced group	Balanced Anesthesia	General anesthesia is induced with propofol and maintained with desflurane.
remimazolam group	Remimazolam	General anesthesia is induced and maintained with remimazolam.

Primary Outcome Measures

Name	Time	Method
Intraoperative hypotension	During surgery	Target Systolic Blood Pressure \< 80%

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of