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Effects of Sufentanil on the Intraoperative Hemodynamics

Primary Purpose

Intraoperative Hypotension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sufentanil
Remifentanil
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Hypotension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 opioid pregnant MAO Inhibitor user Severe respiratory insufficiency

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    sufentanil group

    remifentanil group

    Arm Description

    sufentanil is administered for analgesic during general anesthesia

    remifentanil is administered for analgesic during general anesthesia

    Outcomes

    Primary Outcome Measures

    Intraoperative hypotension
    Target systolic blood pressure < 90%

    Secondary Outcome Measures

    Inotropic requirements
    cumulative doses of inotropics during surgery
    Incidence of bradycardia
    heart rate < 40/min
    Incidence of tachycardia
    heart rate > 100/min
    Maximum systolic blood pressure
    maximal systolic blood pressure
    Minimum systolic blood pressure
    minimal systolic blood pressure

    Full Information

    First Posted
    October 13, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06091904
    Brief Title
    Effects of Sufentanil on the Intraoperative Hemodynamics
    Official Title
    Effects of Sufentanil on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2024 (Anticipated)
    Study Completion Date
    November 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is a randomized, controlled trial. A total of 92 patients will be randomized to receive sufentanil or remifentanil during extracranial-intracranial bypass surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intraoperative Hypotension

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    92 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sufentanil group
    Arm Type
    Experimental
    Arm Description
    sufentanil is administered for analgesic during general anesthesia
    Arm Title
    remifentanil group
    Arm Type
    Active Comparator
    Arm Description
    remifentanil is administered for analgesic during general anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    Sufentanil
    Intervention Description
    Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml
    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil
    Intervention Description
    Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml
    Primary Outcome Measure Information:
    Title
    Intraoperative hypotension
    Description
    Target systolic blood pressure < 90%
    Time Frame
    During surgery
    Secondary Outcome Measure Information:
    Title
    Inotropic requirements
    Description
    cumulative doses of inotropics during surgery
    Time Frame
    During surgery
    Title
    Incidence of bradycardia
    Description
    heart rate < 40/min
    Time Frame
    During surgery
    Title
    Incidence of tachycardia
    Description
    heart rate > 100/min
    Time Frame
    During surgery
    Title
    Maximum systolic blood pressure
    Description
    maximal systolic blood pressure
    Time Frame
    During surgery
    Title
    Minimum systolic blood pressure
    Description
    minimal systolic blood pressure
    Time Frame
    During surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 opioid pregnant MAO Inhibitor user Severe respiratory insufficiency
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chang-Hoon Koo
    Phone
    +821085098841
    Email
    vollock9@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chang-Hoon Koo
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Sufentanil on the Intraoperative Hemodynamics

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