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Hypotension After Anesthetic Induction With Remimazolam in Elderly

Primary Purpose

Hypotension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bolus of remimazolam
Continuous infusion of remimazolam
Sponsored by
Kangbuk Samsung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypotension

Eligibility Criteria

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

Inclusion Criteria:

  • Elderly patients with age over 60 years old
  • scheduled for elective surgery under general anesthesia
  • American Society of Anesthesiology Physical Status I-III

Exclusion Criteria:

  • Arrhythmia
  • Liver dysfunction
  • Kidney dysfunction
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Allergic to benzodiazepines
  • Heart failure
  • Drug intoxication
  • Alcoholics
  • Cognitive dysfunction
  • Unable to understand and consent voluntarily

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Bolus

    Continuous

    Arm Description

    Remimazolam bolus injection for 20 seconds

    Remimazolam continuous infusion

    Outcomes

    Primary Outcome Measures

    The incidence of hypotension
    Systolic blood pressure < 90 mmHg

    Secondary Outcome Measures

    The incidence of bradycardia
    Heart rate < 40 beats per minute
    Number of participants with use of any vasopressors
    Use of ephedrine, phenylephrine
    Lowest systolic blood pressure
    The lowest systolic blood pressure measured within10 minutes after intubation
    Time to loss of consciousness
    Time to loss of consciousness. Loss of consciousness is assessed by the loss of response to shoulder shaking.
    Total remimazolam used for anesthetic induction
    Sum of remimazolam used during anesthetic induction

    Full Information

    First Posted
    September 8, 2022
    Last Updated
    May 31, 2023
    Sponsor
    Kangbuk Samsung Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05538741
    Brief Title
    Hypotension After Anesthetic Induction With Remimazolam in Elderly
    Official Title
    Comparison of the Incidence of Hypotension With Bolus Versus Continuous Remimazolam for Anesthetic Induction in Elderly Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 15, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kangbuk Samsung 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
    Even though remimazolam is known to be safely administered without hemodynamic instability, hypotension is the one of the common side effects of remimazolam. Because elderly patients are susceptible to hypotension due to old age, multimodality, and multiple medications, hypotension can be harmful in elderly patients. Remimazolam can be administered either bolus or continuous for anesthetic induction. In our study the investigators aimed to compare the incidence of hypotension after anesthetic induction using remimazolam by bolus injection and continuous infusion in elderly patients.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bolus
    Arm Type
    Experimental
    Arm Description
    Remimazolam bolus injection for 20 seconds
    Arm Title
    Continuous
    Arm Type
    Active Comparator
    Arm Description
    Remimazolam continuous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Bolus of remimazolam
    Intervention Description
    0.19-0.25 mg/kg for 60-80 years old 0.14-0.19 mg/kg for >80 years old
    Intervention Type
    Drug
    Intervention Name(s)
    Continuous infusion of remimazolam
    Intervention Description
    12 mg/kg/hr until loss of consciousness
    Primary Outcome Measure Information:
    Title
    The incidence of hypotension
    Description
    Systolic blood pressure < 90 mmHg
    Time Frame
    10 minutes after intubation
    Secondary Outcome Measure Information:
    Title
    The incidence of bradycardia
    Description
    Heart rate < 40 beats per minute
    Time Frame
    10 minutes after intubation
    Title
    Number of participants with use of any vasopressors
    Description
    Use of ephedrine, phenylephrine
    Time Frame
    10 minutes after intubation
    Title
    Lowest systolic blood pressure
    Description
    The lowest systolic blood pressure measured within10 minutes after intubation
    Time Frame
    10 minutes after intubation
    Title
    Time to loss of consciousness
    Description
    Time to loss of consciousness. Loss of consciousness is assessed by the loss of response to shoulder shaking.
    Time Frame
    10 minutes after intubation
    Title
    Total remimazolam used for anesthetic induction
    Description
    Sum of remimazolam used during anesthetic induction
    Time Frame
    10 minutes after intubation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Elderly patients with age over 60 years old scheduled for elective surgery under general anesthesia American Society of Anesthesiology Physical Status I-III Exclusion Criteria: Arrhythmia Liver dysfunction Kidney dysfunction Uncontrolled hypertension Uncontrolled diabetes mellitus Allergic to benzodiazepines Heart failure Drug intoxication Alcoholics Cognitive dysfunction Unable to understand and consent voluntarily
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eunah Cho, PhD
    Phone
    82-2-2001-4657
    Email
    mintflavored@naver.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eunah Cho, PhD
    Organizational Affiliation
    Assistant Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Hypotension After Anesthetic Induction With Remimazolam in Elderly

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