Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension

Study Overview
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Brief Summary
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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.

Official Title
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Electrical Acupoint Stimulation Alleviates Hypotension After Spinal Anesthesia in Parturients: a Prospective Randomized Controlled Clinical Trial

Conditions
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Hypotension During Surgery

Intervention / Treatment
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* Other: high frequency acupoint stimulation
* Other: low frequency acupoint stimulation
* Other: electrodes attached


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: control<br> | Other: electrodes attached<br>* electrodes are attached to area of acupoints<br>|
| Experimental: low frequency stimulation<br> | Other: low frequency acupoint stimulation<br>* electrodes are attached to area of acupoints and electrical stimulation at 2/10 Hz is given<br>Other: electrodes attached<br>* electrodes are attached to area of acupoints<br>|
| Experimental: high frequency stimulation<br> | Other: high frequency acupoint stimulation<br>* electrodes are attached to area of acupoints and electrical stimulation at 10/50 Hz is given<br>Other: electrodes attached<br>* electrodes are attached to area of acupoints<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lowest systolic blood pressure during 30 minutes after spinal anesthesia |  | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | 
| dose of ephedrine | hypotension is treated with ephedrine in increments of 10 mg every 2 minutes | from injection of anesthetics to 30 minutes after injection, in a total of 30 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. | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | 
| incidence of dizzy |  | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | 
| incidence of apnea |  | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | 
| incidence of chest congestion |  | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | 
| dose of atropine | Heart rate lower than 50 beats per minute is treated with 0.5mg of atropine | from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes | 
| 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. | 1minute after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcutaneous electrical acupoint stimulation, spinal anesthesia, hypotension