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

Ankara City Hospital Bilkent200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

200

Conditions

Acupuncture Laryngeal Mask Airway Pain, Postoperative Sore Throat

Interventions

acupunctureOTHER

P6, LI4 and LI 11 stimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who recieved general anesthesia with LMA * surgery duration \< 2 hours * between 18-60 years of age * ASA1-2 scores Exclusion Criteria: 1. Being younger than 18 years old or being over the age of 60 2. Patients with an ASA score of 3 and greater than 3 3. Active infections in the area to be acupuncture. 4. Prolonged bleeding time 5. Liver failure 6. Renal insufficiency 7. Pregnancy 8. 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

Locations (1)

Ankara City Hospital Bilkent

Ankara, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: baseline to 24 hours

Secondary Outcomes

duration of operation

Time frame: 24 hour

resistance to Laringeal mask placement (none, mild, moderate, severe)

1. none 2. mild 3. moderate 4. severe

Time frame: 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

Time frame: 24 hours

Central Contacts

FERYAL AKÇAY

CONTACT

+905459735654 feryalkakcay@gmail.com

TUNAHAN ÇEVİK

CONTACT

+905459735654 drtunahanceviknumune@gmail.com

Data from ClinicalTrials.gov

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