TEAS Reduces Remifentanil Consumption

Study Overview
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Brief Summary
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Transcutaneous electrical acupoint stimulation (TEAS) has been shown to decrease the need of opioids including remifentanil during anaesthesia. However, it is not clear whether combination of two or more acupoints could induce stronger analgesia. Moreover, evidence for the long-term effect of TEAS has been limited. The present study was to compare the short-term and long-term effect on pain of dual-acupoint and single-acupoint TEAS.

Official Title
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Effect of Transcutaneous Electrical Acupoint Stimulation on Remifentanil Consumption and Postoperative Pain in Patients Undergoing Radical Mastectomy

Conditions
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Anesthesia, Pain

Intervention / Treatment
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* Device: acupoint stimulation
* Device: single acupoint
* Device: dual acupoints


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 65 yrs body mass index (BMI) of 18 to 30 kg/m2 elective radical mastectomy under general anaesthesia Exclusion Criteria: contradictions to TEAS difficulties in communication histories of general anaesthesia drug or alcohol abuse or addiction cardiac dysfunction or severe hypertension confirmed hepatic dysfunction and renal impairment the participants recruited into other clinical trials during last three months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: single acupoint stimulation<br> | Device: acupoint stimulation<br> <br> Device: single acupoint<br> <br> |
| Experimental: dual acupoints stimulation<br> | Device: acupoint stimulation<br> <br> Device: dual acupoints<br> <br> |
| No Intervention: no stimulation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of remifentanil |  | from start of anesthesia to extubation, on average 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to recall |  | from end of remifentanil infusion to patient response to verbal command,approximately 10 minutes on average | 
| time to extubation |  | from end of remifentanil infusion to extubation,approximately 10 minutes on average | 
| respiratory depression |  | end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes | 
| nausea and vomiting |  | end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes | 
| visual analogue scale of pain | pain intensity is assessed by a 0-10mm scale, 0 is no pain, 10 is untolerated pain | end of the surgery to discharge from postanesthesia care unit,with an average of 30 minutes | 
| patients' satisfaction score | patients' satisfaction score is assessed by a 0-10mm scale, 0 is no pain, 10 is untolerated pain | from end of surgery to 24 hours after surgery, totally 24 hours | 
| incidence of pain at 3m after surgery | percentage of patients suffering from pain around the incision | from discharge from hospital to 3 months after surgery, approximately 3 months | 
| incidence of pain at 6m after surgery | percentage of patients suffering from pain around the incision | from discharge from hospital to 6 months after surgery, approximately 3 months |