Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask

Study Overview
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Brief Summary
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the aim of our study is to investigate if stimulation of the P6, LI4 and LI11 acupuncture points via laser acupuncture prevents sore throat caused by the classic laryngeal mask.

Detailed Description
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Our study is planned as a prospective, randomized, controlled, single blind. The details of the study are explained to the patients and their written informed consents are obtained. Using the randomization program, the patients are divided into group 1 (acupuncture group) and group 2 (control group). Preoxygenation (100% oxygen with balloon and mask for 3 minutes) and midozolam 0.02 mg / kg and fentanyl 2 mcgr / kg are administered to both groups. In Group1, laser acupuncture is applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds. In Group 2, same procedure is performed for 30 seconds while laser acupuncture closed. Then, propofol 2mg / kg is administered and a laryngeal mask is placed after 90 seconds in both groups. Maintenance anesthesia is provided with sevofurane and remifentanil infusion.

Official Title
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Effectiveness of Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask

Conditions
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Pain, Postoperative, Acupuncture, Laryngeal Mask Airway, Sore Throat

Intervention / Treatment
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* Other: acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who recieved general anesthesia with LMA surgery duration < 2 hours between 18-60 years of age ASA1-2 scores Exclusion Criteria: Being younger than 18 years old or being over the age of 60 Patients with an ASA score of 3 and greater than 3 Active infections in the area to be acupuncture. Prolonged bleeding time Liver failure Renal insufficiency Pregnancy Heart failure 9 . Patients less than 30 kg 10. Uncontrolled hypertension 11. Uncontrolled diabetes, pheochrocytoma, thyroid dysfunction 12. Those who do not have the ability to read and sign the consent form 13. Patients with gastroesophageal reflux 14. History of any herbal medicine use 15. Patients who do not want to sign the consent form 16. Patients with difficult LMA placement 17.Patients who cannot have LMA placement at one time 18. Intubated patients in whom LMA could not be placed 19 Patients whose operation time exceeds two hours 20 .Patients whose operation time is less than 30 minutes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: prospective randomized controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: acupuncture<br>Group1, laser acupuncture was applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds | Other: acupuncture<br>* P6, LI4 and LI 11 stimulation<br>|
| Sham Comparator: false acupuncture<br>P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds while laser acupuncture closed | Other: acupuncture<br>* P6, LI4 and LI 11 stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline sore throat at 24 h | postoperative sore throat is evaluated at 0th, 2th, 6th, 12th, 24th hours with using no, mild, moderate, severe scale. | baseline to 24 hours | 
| Change from Baseline postoperative cough at 24 hours | postoperative cough is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent | baseline to 24 hours | 
| Change from Baseline postoperative snoring at 24 hours | postoperative snoring is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent | baseline to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of operation |  | 24 hour | 
| resistance to Laringeal mask placement (none, mild, moderate, severe) | none mild moderate severe | 24 hours | 
| time taken for Laringeal mask placement (opening of the mouth for placement and time to confirmation of LMA placement with capnograph and auscultation | time from opening of the mouth for placement to confirmation of LMA placement with capnograph and auscultation | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sore Throat, Laryngeal Mask Airway, Acupuncture