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Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension (EARTH)

Primary Purpose

Hypotension During Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high frequency acupoint stimulation
low frequency acupoint stimulation
electrodes attached
Sponsored by
Zhihong LU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension During Surgery focused on measuring transcutaneous electrical acupoint stimulation, spinal anesthesia, hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: age ≥18 years American Society of Anesthesiologists physical status Ⅰ-Ⅱ singleton pregnancy full-term gestation (≥38 weeks) Exclusion Criteria: Parturients suffering from preeclampsia Parturients with hypertension, diabetes, or cardiac dysfunction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Sham Comparator

    Experimental

    Experimental

    Arm Label

    control

    low frequency stimulation

    high frequency stimulation

    Arm Description

    Outcomes

    Primary Outcome Measures

    incidence of hypotension by 30 minutes after spinal anesthesia
    Hypotension episodes, defined as reductions in systolic blood pressure exceeding 30% of baseline or <90 mm Hg

    Secondary Outcome Measures

    lowest systolic blood pressure during 30 minutes after spinal anesthesia
    dose of ephedrine
    hypotension is treated with ephedrine in increments of 10 mg every 2 minutes
    nausea and vomiting score
    The presence of nausea and vomiting is measured on a 3-point scale of 1, 2, and 3, indicating no nausea and no vomiting, nausea only, and both nausea and vomiting, respectively.
    incidence of dizzy
    incidence of apnea
    incidence of chest congestion
    dose of atropine
    Heart rate lower than 50 beats per minute is treated with 0.5mg of atropine
    Apgar score at 1 minute
    Apgar score of the neonates at 1minute after birth. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.

    Full Information

    First Posted
    February 2, 2023
    Last Updated
    February 2, 2023
    Sponsor
    Zhihong LU
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05724095
    Brief Title
    Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension
    Acronym
    EARTH
    Official Title
    Electrical Acupoint Stimulation Alleviates Hypotension After Spinal Anesthesia in Parturients: a Prospective Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 5, 2023 (Anticipated)
    Primary Completion Date
    April 6, 2023 (Anticipated)
    Study Completion Date
    April 7, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Zhihong LU

    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
    The parturients may suffer from hypotension after spinal anesthesia and the incidence could be as high as 70-80% when pharmacological prophylaxis is not used. Acupuncture was reported to treat hypotension both in human and animal studies. Possible mechanisms include modulating cardiovascular and sympathetic system. In this prospective, double-blinded, randomized clinical trial, we tend to investigate the effect of transcutaneous electric acupoint stimulation (TEAS) on hypotension in parturients undergoing cesarean section.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension During Surgery
    Keywords
    transcutaneous electrical acupoint stimulation, spinal anesthesia, hypotension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    Sham Comparator
    Arm Title
    low frequency stimulation
    Arm Type
    Experimental
    Arm Title
    high frequency stimulation
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    high frequency acupoint stimulation
    Intervention Description
    electrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given
    Intervention Type
    Other
    Intervention Name(s)
    low frequency acupoint stimulation
    Intervention Description
    electrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given
    Intervention Type
    Other
    Intervention Name(s)
    electrodes attached
    Intervention Description
    electrodes are attached to area of acupoints
    Primary Outcome Measure Information:
    Title
    incidence of hypotension by 30 minutes after spinal anesthesia
    Description
    Hypotension episodes, defined as reductions in systolic blood pressure exceeding 30% of baseline or <90 mm Hg
    Time Frame
    from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
    Secondary Outcome Measure Information:
    Title
    lowest systolic blood pressure during 30 minutes after spinal anesthesia
    Time Frame
    from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
    Title
    dose of ephedrine
    Description
    hypotension is treated with ephedrine in increments of 10 mg every 2 minutes
    Time Frame
    from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
    Title
    nausea and vomiting score
    Description
    The presence of nausea and vomiting is measured on a 3-point scale of 1, 2, and 3, indicating no nausea and no vomiting, nausea only, and both nausea and vomiting, respectively.
    Time Frame
    from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
    Title
    incidence of dizzy
    Time Frame
    from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
    Title
    incidence of apnea
    Time Frame
    from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
    Title
    incidence of chest congestion
    Time Frame
    from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
    Title
    dose of atropine
    Description
    Heart rate lower than 50 beats per minute is treated with 0.5mg of atropine
    Time Frame
    from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
    Title
    Apgar score at 1 minute
    Description
    Apgar score of the neonates at 1minute after birth. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.
    Time Frame
    1minute after birth

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ≥18 years American Society of Anesthesiologists physical status Ⅰ-Ⅱ singleton pregnancy full-term gestation (≥38 weeks) Exclusion Criteria: Parturients suffering from preeclampsia Parturients with hypertension, diabetes, or cardiac dysfunction
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhihong Lu
    Phone
    +8613891975018
    Email
    deerlu23@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17959591
    Citation
    Arai YC, Kato N, Matsura M, Ito H, Kandatsu N, Kurokawa S, Mizutani M, Shibata Y, Komatsu T. Transcutaneous electrical nerve stimulation at the PC-5 and PC-6 acupoints reduced the severity of hypotension after spinal anaesthesia in patients undergoing Caesarean section. Br J Anaesth. 2008 Jan;100(1):78-81. doi: 10.1093/bja/aem306. Epub 2007 Oct 24.
    Results Reference
    result
    PubMed Identifier
    20632667
    Citation
    Adigun TA, Amanor-Boadu SD, Soyannwo OA. Comparison of intravenous ephedrine with phenylephrine for the maintenance of arterial blood pressure during elective caesarean section under spinal anaesthesia. Afr J Med Med Sci. 2010 Mar;39(1):13-20.
    Results Reference
    result
    PubMed Identifier
    32619039
    Citation
    Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4.
    Results Reference
    result

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    Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension

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