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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture | Active Comparator | 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 |
|
| false acupuncture | Sham Comparator | P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds while laser acupuncture closed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | P6, LI4 and LI 11 stimulation |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| duration of operation | 24 hour | |
| resistance to Laringeal mask placement (none, mild, moderate, severe) |
| 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| FERYAL AKÇAY | Contact | +905459735654 | feryalkakcay@gmail.com | |
| TUNAHAN ÇEVİK | Contact | +905459735654 | drtunahanceviknumune@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| FERYAL AKÇAY | Ankara City Hospital Bilkent | Principal Investigator |
| FERYAL AKÇAY | Ankara City Hospital Bilkent | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara City Hospital Bilkent | Recruiting | Ankara | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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prospective randomized controlled study
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double blind
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |