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NCT05557253 | Recruiting | Intraoperative Hypotension

Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery
Sponsor:

Seoul National University Hospital

Information provided by (Responsible Party):

Chung-hoon Koo

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.

Condition or disease

Intraoperative Hypotension

Intervention/treatment

Remimazolam

Balanced Anesthesia

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 72 participants
Masking : Double
Primary Purpose : Prevention
Official Title : Effects of Remimazolam on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial
Actual Study Start Date : October 20, 2022
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : December 30, 2023
Arm Intervention/treatment

Experimental: remimazolam group

General anesthesia is induced and maintained with remimazolam.

Drug: Remimazolam

Active Comparator: balanced group

General anesthesia is induced with propofol and maintained with desflurane.

Drug: Balanced Anesthesia
Ages Eligible for Study: 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
  • 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
Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

Location Details

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Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Korea, Republic of, Gyeonggi-do

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620