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Effect of Acupoint Electrical Stimulation on Incidence of Hypotension After Spinal Anesthesia

Primary Purpose

Anesthesia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous electric stimulation pretreatment
Transcutaneous acupoint electrical stimulation treatment
Transcutaneous acupoint pseudo electric stimulation
Sponsored by
Shanghai Tongji Hospital, Tongji University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 90>65, regardless of gender; ASA classification I-III; ③ Orthopedic surgery was performed under spinal anesthesia; ④ Sign the informed consent form. Exclusion Criteria: Uncontrolled hypertension; Arrhythmia or myocardial ischemia; Severe cardiopulmonary insufficiency; HB<100g/L; Severe dehydration; ⑥ There are contraindications to spinal anesthesia; ⑦ Allergies to local anesthetics; Communication barriers; ⑨ Refusing to sign the informed consent form.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Sham Comparator

    Arm Label

    Transcutaneous electric stimulation pretreatment group

    Transcutaneous acupoint electrical stimulation treatment group

    Transcutaneous acupoint pseudo electric stimulation group

    Arm Description

    30 minutes before the implementation of spinal anesthesia, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points.

    Within 30 minutes after the occurrence of hypotension, TEAS (density wave 10/50Hz, one side of Neiguan point and Quchi point connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points.

    Paste the electrode, turn on the power, but no current output.

    Outcomes

    Primary Outcome Measures

    Incidence of hypotension
    30 mins after anesthesia, hypotension was defined as MAP<25% of the baseline value

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2023
    Last Updated
    February 6, 2023
    Sponsor
    Shanghai Tongji Hospital, Tongji University School of Medicine
    Collaborators
    ShuGuang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05716399
    Brief Title
    Effect of Acupoint Electrical Stimulation on Incidence of Hypotension After Spinal Anesthesia
    Official Title
    Effect of Transcutaneous Electrical Stimulation of Acupoints on the Incidence of Hypotension After Spinal Anesthesia in Elderly Patients Undergoing Orthopaedic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 20, 2023 (Anticipated)
    Primary Completion Date
    December 20, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Tongji Hospital, Tongji University School of Medicine
    Collaborators
    ShuGuang Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study is intended to include elderly patients who are selected to undergo lower limb and pelvic orthopedic surgery under spinal anesthesia. Through prospective, randomized and controlled clinical trials, the investigators will observe the effect of this treatment on the incidence of hypotension in elderly patients after spinal anesthesia through TEAS points Neiguan and Quchi before or during surgery, and further explore its related mechanisms.
    Detailed Description
    Research content: This study aims to observe whether TEAS intervention on Neiguan (PC-6) and Quchi (LI-11) before and during operation can improve the incidence and degree of hypotension after spinal anesthesia, as well as the changes of neurotransmitters and related hormones in blood. Research methods: 111 elderly patients (including hip or lower limb fractures, hip and knee joint replacement or debridement) who were selected for lower limb or pelvic surgery under spinal anesthesia were randomly divided into percutaneous point electrical stimulation pretreatment group (PTEAS group), percutaneous point electrical stimulation treatment group (TEAS group) and percutaneous point pseudo electrical stimulation group (FTEAS group). After entering the operating room, the vital signs were monitored routinely, and the volume was evaluated by measuring the variability of the inferior vena cava with ultrasound before anesthesia. Then, the radial artery was punctured and catheterized, and sodium lactate was infused (8ml/Kg). Within 30 minutes before spinal anesthesia or 30 minutes after hypotension, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points, and the current intensity was only as high as the patient could comfortably tolerate (the electrical stimulation intensity was 2-3 times of the sensory threshold, for example, if the electrical stimulation intensity was 5 mA, 10-15 mA was used for stimulation), Record the specific value of current. FTEAS group pastes electrode piece, turns on the power, but there is no current output. Select L2/3 or L3/4 interval for spinal anesthesia, use 0.75% cloth ratio, and the dose standard is 0.025ml/Kg. Collect venous blood after entering the operating room and 30 minutes after anesthesia to measure the levels of neurotransmitters and hormones, record the baseline value of vital signs and changes during operation, observe the occurrence and treatment of adverse events during operation, and follow up the troponin T level and the incidence of delirium after operation. Remedial measures for clinical safety: When severe hypotension occurs during operation, which leads to irreversible adverse effects, it needs to be intervened by multiple means. Those who are diagnosed as delirium through CAM determination shall be treated with haloperidol or dexmedetomidine.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    In order to ensure the objectivity and reliability of the study, the statistical analysts are blinded, and the subjects and operators are not blind. The operator is responsible for the implementation of anesthesia, the connection and use of TEAS, and data collection; The statistical analyst is responsible for data entry, data sorting and statistical analysis.
    Allocation
    Randomized
    Enrollment
    111 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Transcutaneous electric stimulation pretreatment group
    Arm Type
    Experimental
    Arm Description
    30 minutes before the implementation of spinal anesthesia, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points.
    Arm Title
    Transcutaneous acupoint electrical stimulation treatment group
    Arm Type
    Active Comparator
    Arm Description
    Within 30 minutes after the occurrence of hypotension, TEAS (density wave 10/50Hz, one side of Neiguan point and Quchi point connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points.
    Arm Title
    Transcutaneous acupoint pseudo electric stimulation group
    Arm Type
    Sham Comparator
    Arm Description
    Paste the electrode, turn on the power, but no current output.
    Intervention Type
    Device
    Intervention Name(s)
    Transcutaneous electric stimulation pretreatment
    Intervention Description
    Within 30 minutes before spinal anesthesia or 30 minutes after hypotension, TEAS (density wave 10/50Hz, one side of Neiguan and Quchi points connected to two electrodes on the same wire on the electroacupuncture instrument) was continuously performed on both sides of Neiguan and Quchi points, and the current intensity was only as high as the patient could comfortably tolerate (the electrical stimulation intensity was 2-3 times of the sensory threshold, for example, if the electrical stimulation intensity was 5 mA, 10-15 mA was used for stimulation), Record the specific value of current. FTEAS group pastes electrode piece, turns on the power, but there is no current output.
    Intervention Type
    Device
    Intervention Name(s)
    Transcutaneous acupoint electrical stimulation treatment
    Intervention Description
    Transcutaneous acupoint electrical stimulation treatment
    Intervention Type
    Device
    Intervention Name(s)
    Transcutaneous acupoint pseudo electric stimulation
    Intervention Description
    Transcutaneous acupoint pseudo electric stimulation
    Primary Outcome Measure Information:
    Title
    Incidence of hypotension
    Description
    30 mins after anesthesia, hypotension was defined as MAP<25% of the baseline value
    Time Frame
    30 mins after anesthesia

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 90>65, regardless of gender; ASA classification I-III; ③ Orthopedic surgery was performed under spinal anesthesia; ④ Sign the informed consent form. Exclusion Criteria: Uncontrolled hypertension; Arrhythmia or myocardial ischemia; Severe cardiopulmonary insufficiency; HB<100g/L; Severe dehydration; ⑥ There are contraindications to spinal anesthesia; ⑦ Allergies to local anesthetics; Communication barriers; ⑨ Refusing to sign the informed consent form.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shaorui Gu, Doctor
    Phone
    051866111070
    Email
    870005908@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wenli Wang, Doctor
    Organizational Affiliation
    Shanghai Tongji Hospital, Tongji University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Acupoint Electrical Stimulation on Incidence of Hypotension After Spinal Anesthesia

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