Study the Effect of Electroacupuncture on Prevention and Treatment of Hypotension After Intraspinal Anesthesia

Study Overview
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Brief Summary
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The purpose of this study is to assess the prevention and treatment effect of transcutaneous acupoint electrical stimulation on hypotension after intraspinal anesthesia.

Detailed Description
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After being informed about the study and potential risks, all patients giving written informed consent will undergo the doctors' and researchers' examination to determine eligibility for study entry. At beginning of the study, patients who meet the eligibility requirements will be randomized in a open manner（participant and electroacupuncture executor）in a 1:1 ratio to TEAS group (10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration) or Control group (Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group).

Official Title
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Based on Non-invasive Cardiac Output Monitoring System to Explore the Preventive and Therapeutic Effect of Transcutaneous Acupoint Electrical Stimulation on Hypotension After Intraspinal Anesthesia in Cesarean Section

Conditions
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Hypotension

Intervention / Treatment
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* Other: transcutaneous acupoint electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years ≤ age < 55 years ASA classification I   II full term (37 weeks ≤ gestational weeks < 42 weeks) fchedule for elective single cesarean section under spinal anesthesia no other clinical trial 3 months before the enrollment volunteer to participate and sign the informed consent form Exclusion Criteria: severe preeclampsia or hypertension diabetes cardiac insufficiency mental abnormality or cognitive impairment or inability to communicate acupuncture points skin breakage, infection, allergy the researchers believe that there are any conditions that are not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: TEAS group: 10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration. Control group: Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEAS group<br>10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration. | Other: transcutaneous acupoint electrical stimulation<br>* The corresponding transcutaneous acupoint electrical stimulation is given to different groups before spinal anesthesia, which last from 10 minutes before anesthesia to 30 minutes after subarachnoid administration.<br>|
| No Intervention: Control group<br>Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hypotension | the incidence of hypotension within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group. | within 30 minutes after subarachnoid administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specific changes of hemodynamic indexes | compared with Control group, the changes of hemodynamic indexes in TEAS group were more stable. | within 30 minutes after subarachnoid administration | 
| usage of ephedrine | the usage of ephedrine within 30 minutes after subarachnoid administration in TEAS group was significantly less than that in Control group. | within 30 minutes after subarachnoid administration | 
| incidence of nausea and vomiting | the incidence of nausea and vomiting within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group. | within 30 minutes after subarachnoid administration | 
| incidence of dizziness, chest tightness and dyspnea | the incidence of dizziness, chest tightness and dyspnea within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group. | within 30 minutes after subarachnoid administration |