Evaluation of PC 6 Neiguan With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.

Study Overview
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Brief Summary
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Assessment of the effectiveness of PC 6 Neiguan with conventional acupuncture for preventing PONV (PostOperative Nausea and Vomiting) after laparoscopic surgery.

Detailed Description
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Utilizing acustimulation, the effect of PC 6 Neiguan (acupuncture point Pericardium 6) has been studied in PONV . Conventional acupuncture has not been tested yet in laparoscopic cholecystectomy. The incidence of postoperative vomiting during the first 24 hours is the main outcome. Secondary outcomes include: complete response rate, total rescue ondansetron dose used and patient satisfaction with PONV management.

Official Title
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Evaluation of PC 6 Neiguan With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.

Conditions
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Cholecystitis, Vomiting, Nausea

Intervention / Treatment
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* Other: stimulation
* Other: no stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and male patients > 18 y General anesthesia Undergoing laparoscopic surgery Patient with American Society of Anesthesiologists physical status I-II Written informed consent Exclusion Criteria: Pregnant women and breastfeeding Patient with cardiac disease Surgery more than 2 h No bowel surgery Signs of skin infection at or near the purposed site of the acupuncture point Patient with American Society of Anesthesiologists physical status IIII-IV

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized comparative double blind prospective study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stimulation of the acupuncture point<br>a acupuncture needle and bandage will be applied at pericardium channel 6, point Neiguan | Other: stimulation<br>* activation of the acupuncture point<br>|
| Placebo Comparator: no stimulation of the acupuncture point<br>only a bandage will be applied at pericardium channel 6, point Neiguan | Other: no stimulation<br>* no activation of the acupuncture point<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vomiting and Nausea | numeric from 0-4, 0= no vomiting, 1= nausea, 2= moderate, 3= multiple and 4= extensive | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of antiemetic | dosage in mg | 24 hours | 
| Use of analgesia | dosage in mg | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic, acupuncture