Transcutaneous Electrical Acupoint Stimulation(TEAS) for Postoperative Nausea and Vomiting in Laparoscopic Operation

Study Overview
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Brief Summary
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This is a single center, randomized, double-blinded, controlled clinical trial.The purpose of this study is to compare the effect of TEAS pretreatment with single acupoint or two acupoints for postoperative nausea and vomiting in patients undergoing laparoscopic operation.

Detailed Description
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Patients were randomly assigned to four groups, receiving TEAS 30 minutes before induction.The stimulation was applied until the end of the operation. Postoperative nausea and vomiting was recorded 30 minute, 2 hour, 6 hour and 24 hour after the operation. The adverse events were recorded as well.

Official Title
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Efficiency of Transcutaneous Electrical Acupoint Stimulation(TEAS) With Single Acupoint or Two Acupoints for Postoperative Nausea and Vomiting in Laparoscopic Operation: A Single Center, Randomized, Double-blinded, Controlled Clinical Trial

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Device: TEAS (transcutaneous electrical acupoint stimulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III Aged 18 to 65 years old Scheduled for general anesthesia BMI index is between 18 to 30 Informed consented Exclusion Criteria: ASA IV Hypertension that is not controlled Severe hepatic or renal dysfunction Ever had received electrical stimulation treatment Severe systemic infection With contraindications to the use of TEAS, such as skin damage or infection at the acupoints For any reason one can not cope with the studies, such as the following: language comprehension, mental illness Participate in the other clinical trial 3 month before the enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: shuangxuezu<br>Patients were given 30min of TEAS before induction until the end of the operation at two acupoints. | Device: TEAS (transcutaneous electrical acupoint stimulation)<br>* Electric stimulation was given through electrode attached to specific acupoints<br>|
| Experimental: neiguanxuezu<br>Patients were given TEAS at neiguan acupoint. | Device: TEAS (transcutaneous electrical acupoint stimulation)<br>* Electric stimulation was given through electrode attached to specific acupoints<br>|
| Experimental: zusanlixuezu<br>Patients were given TEAS at Zusanli acupoint. | Device: TEAS (transcutaneous electrical acupoint stimulation)<br>* Electric stimulation was given through electrode attached to specific acupoints<br>|
| Sham Comparator: duizhaozu<br>Patients were not given TEAS at two acupoints. | Device: TEAS (transcutaneous electrical acupoint stimulation)<br>* Electric stimulation was given through electrode attached to specific acupoints<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative nausea and vomiting |  | within 24 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of other postoperative complications |  | 30minutes, 2hours, 6hours and 24 hours after operation | 
| Postoperative nausea and vomiting（PONV） score |  | 30minutes, 2hours, 6hours and 24 hours after operation | 
| Visual Analogue Scale (VAS) pain score in PACU |  | 30 minutes after operation | 
| Change of concentration of serum 5-HT |  | intraoperative | 
| Change of concentration of serum dopamine |  | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative nausea and vomiting, TEAS