Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
- Conditions
- Pain, PostoperativeAcupunctureLaryngeal Mask AirwaySore Throat
- Interventions
- Other: acupuncture
- Registration Number
- NCT04910659
- Lead Sponsor
- Ankara City Hospital Bilkent
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Patients who recieved general anesthesia with LMA
- surgery duration < 2 hours
- between 18-60 years of age
- ASA1-2 scores
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Being younger than 18 years old or being over the age of 60
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Patients with an ASA score of 3 and greater than 3
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Active infections in the area to be acupuncture.
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Prolonged bleeding time
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Liver failure
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Renal insufficiency
-
Pregnancy
-
Heart failure 9 . Patients less than 30 kg
-
Uncontrolled hypertension
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Uncontrolled diabetes, pheochrocytoma, thyroid dysfunction
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Those who do not have the ability to read and sign the consent form
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Patients with gastroesophageal reflux
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History of any herbal medicine use
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Patients who do not want to sign the consent form
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Patients with difficult LMA placement
17.Patients who cannot have LMA placement at one time
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description acupuncture acupuncture 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 acupuncture P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds while laser acupuncture closed
- Primary Outcome Measures
Name Time Method Change from Baseline sore throat at 24 h baseline to 24 hours postoperative sore throat is evaluated at 0th, 2th, 6th, 12th, 24th hours with using no, mild, moderate, severe scale.
Change from Baseline postoperative cough at 24 hours baseline to 24 hours postoperative cough is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
Change from Baseline postoperative snoring at 24 hours baseline to 24 hours postoperative snoring is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
- Secondary Outcome Measures
Name Time Method duration of operation 24 hour resistance to Laringeal mask placement (none, mild, moderate, severe) 24 hours 1. none
2. mild
3. moderate
4. severetime taken for Laringeal mask placement (opening of the mouth for placement and time to confirmation of LMA placement with capnograph and auscultation 24 hours time from opening of the mouth for placement to confirmation of LMA placement with capnograph and auscultation
Trial Locations
- Locations (1)
Ankara City Hospital Bilkent
🇹🇷Ankara, Turkey