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Effect of norepinephrine continuous infusion for the prevention of hypotension after spinal anesthesia with propofol sedation in the elderly

Status Approved

  • First Submitted Date

    2020/04/14

  • Registered Date

    2020/05/21

  • Last Updated Date

    2023/02/08

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005046
    Unique Protocol ID 2020-0533
    Public/Brief Title Effect of norepinephrine for the prevention of hypotension after spinal anesthesia in the elderly
    Scientific Title Effect of norepinephrine continuous infusion for the prevention of hypotension after spinal anesthesia with propofol sedation in the elderly
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted approval
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2020-0533
    Approval Date 2020-04-13
    Institutional Review Board Name Asan Medical Center Institutional Review Board
    Institutional Review Board Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea
    Institutional Review Board Telephone 02-3010-7165
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Hyungtae Kim
    Title associate professor
    Telephone +82-2-3010-3883
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43gil, Songpa-gu, Seoul
    Contact Person for Public Queries
    Name Ha-Jung Kim
    Title assistant professor
    Telephone +82-2-3010-0338
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43gil, Songpa-gu, Seoul
    Contact Person for Updating Information
    Name Ha-Jung Kim
    Title assistant professor
    Telephone +82-2-3010-0338
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43gil, Songpa-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2020-08-16 Actual
    Target Number of Participant 70
    Primary Completion Date 2021-07-01 , Actual
    Study Completion Date 2021-07-01 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Asan Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2020-08-16 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Asan Medical Center
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Asan Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    A recent paper article reported that regional anesthesia has an advantage in clinical outcomes compared to general anesthesia in older patients undergoing hip surgery. However, spinal ansthesia-induced hypotension often occurs in the elderly. Especially, if propofol is administered intravenously for sedation during surgery, the incidence of hypotension could be higher. Perioperative hypotension is associated with imbalance in oxygen demand and supply, causing postoperative cardiac infarction or acute kidney damage. Since elderly patients, in particular, often have multiple comorbidities, these postoperative complications might induce fatal consequences, prevention of perioperative hypotension is critical to improve the patient's prognosis.
    
    In the past, phenylephrine has been commonly used in the management of spinal anesthesia-induced hypotension. However, there have been arguments that using norepinephrine is more effective and safer than using phenylephrine in patients undergoing C-section under spinal anesthesia. Because phenylephrine, the peripheral vasoconstrictor, could cause the bradycardia and reduce cardiac output, it is thought that the use of norepinephrine in the management of hypotension could be an alternative in the elderly whose cardiovascular function is relatively weak. Therefore, we aimed to evaluate whether norepinephrine could effectively prevent hypotension in older patients scheduled to undergo hip surgery under spinal anesthesia with sedation using propofol.
    
    -This study includes 70 patients who signed consent forms among those undergoing hip surgery under spinal anesthesia with sedation using propofol at a tertiary center (Asan Medical Center). The participants are randomly decided into two groups; control group vs norepinephrine group (35 participants in each group).
    - Standard monitoring should be done when the participant arrives in the operating room. Oxygen is supplied using a facial mask to all patients and spinal anesthesia with 10mg of heavy marcaine and 15mcg of fentanyl is performed. At this point, the continuous infusion of drugs(normal saline or norepinephrine) begins according to the assigned group. After 5 minutes, assessment of anesthetic level is performed. Then, start the target controlled infusion of the propofol. Pleth variability index is monitored to evaluate the volume status of participants and normovolema is maintained based on pleth variability index during the surgery. Infusion of propofol and study drug is stopped when the surgery is finished.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Prevention
    Phase Phase4
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    Group C: normal saline-0.15cc/kg/hr, intravenously continuous infusion, from the time point that the participants take the supine position after the intrathecal injection of local anesthetics to the end of surgery
    Group N: norepinephrine-0.15cc/kg/hr (0.05mcg/kg/min),  intravenously continuous infusion, from the time point that the participants take the supine position after the intrathecal injection of local anesthetics to the end of surgery
    
    There is no difference in anesthetic management in each group except the drug intravenously administered; normal saline vs norepinephrine.
    Number of Arms 2
    Arm 1

    Arm Label

    Group C

    Target Number of Participant

    35

    Arm Type

    Placebo comparator

    Arm Description

    Group C: normal saline-0.15cc/kg/hr, intravenously continuous infusion, from the time point that the participants take the supine position after the intrathecal injection of local anesthetics to the end of surgery
    Arm 2

    Arm Label

    Group N

    Target Number of Participant

    35

    Arm Type

    Experimental

    Arm Description

    Group N: norepinephrine-0.15cc/kg/hr (0.05mcg/kg/min),  intravenously continuous infusion, from the time point that the participants take the supine position after the intrathecal injection of local anesthetics to the end of surgery
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M16.9)Coxarthrosis, unspecified 

    Patients who are scheduled to undergo a hip surgery
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    70Year~No Limit

    Description

    * American Society of Anesthesiologists Physical Status 1-3
    * age: equal to or older than 70 years
    * patients scheduled to undergo a hip surgery under spinal anesthesia with propofol sedation
    Exclusion Criteria
    * patients who don't agree to participate in this study
    * patients with uncontrolled hypertension, hyperthyroidism, dementia, symptomatic coronary artery disease, or hemoglobin <10g/dL
    * patients with allergy to propofol, fentanyl, or bupivacaine
    * patients who are cont coagulopathy, severe aortic stenosis/mitral stenosis, active infection on lumbar region
    * patients who are judged to be inappropriate for this study by authors
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    number of hypotensive episodes
    Timepoint
    intraoperative period
    Secondary Outcome(s) 1
    Outcome
    number of hypertensive episodes
    Timepoint
    intraoperative period
    Secondary Outcome(s) 2
    Outcome
    total amount of phenylephrine administered
    Timepoint
    intraoperative period
    Secondary Outcome(s) 3
    Outcome
    total amount of administered fluid
    Timepoint
    intraoperative
    Secondary Outcome(s) 4
    Outcome
    number of hypotensive episodes
    Timepoint
    during recovery period at post-anesthetic care unit
    Secondary Outcome(s) 5
    Outcome
    complications
    Timepoint
    postoperative period
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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