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Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery

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ClinicalTrials.gov Identifier: NCT05557253
Recruitment Status : Recruiting
First Posted : September 27, 2022
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
Chang-Hoon Koo, 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.

Condition or disease Intervention/treatment Phase
Intraoperative Hypotension Drug: Remimazolam Drug: Balanced Anesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: remimazolam group
General anesthesia is induced and maintained with remimazolam.
Drug: Remimazolam
Anesthesia induction: remimazolam 6-12 mg/kg/h Anesthesia maintenance: remimazolam 1-2 mg/kg/h

Active Comparator: balanced group
General anesthesia is induced with propofol and maintained with desflurane.
Drug: Balanced Anesthesia
Anesthesia induction: propofol 1.5-2 mg/kg Anesthesia maintenance: Desflurane 6-8 vol%




Primary Outcome Measures :
  1. Intraoperative hypotension [ Time Frame: During surgery ]
    Target Systolic Blood Pressure < 80%


Secondary Outcome Measures :
  1. Inotropic requirements [ Time Frame: During surgery ]
    Dose of inotropics administered during surgery

  2. Incidence of bradycardia [ Time Frame: During surgery ]
    heart rate < 40 /min

  3. Incidence of tachycardia [ Time Frame: During surgery ]
    heart rate > 100 /min

  4. Maximum systolic blood pressure [ Time Frame: During surgery ]
    Maximal systolic blood pressure during surgery (mmHg)

  5. Minimum systolic blood pressure [ Time Frame: During surgery ]
    Minimal systolic blood pressure during surgery (mmHg)

  6. Brain relaxation score [ Time Frame: Immediately after dura opening ]
    1=perfectly relaxed, 2=satisfactorily relaxed, 3=firm brain, 4=bulging brain



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05557253


Contacts
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Contact: Chang-Hoon Koo +821085098841 vollock9@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Chang-Hoon Koo       vollock9@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Chang-Hoon Koo Seoul National University Bundang Hospital
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Responsible Party: Chang-Hoon Koo, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT05557253    
Other Study ID Numbers: Bypass-RMDZ
First Posted: September 27, 2022    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs