Clinical trial NCT04910659: Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
Official title: Effectiveness of Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Laryngeal Mask Airway
Pain, Postoperative
Sore Throat
Keywords: Sore Throat
Laryngeal Mask Airway
Acupuncture
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline sore throat at 24 h
timeFrame: baseline to 24 hours
measure: Change from Baseline postoperative cough at 24 hours
timeFrame: baseline to 24 hours
measure: Change from Baseline postoperative snoring at 24 hours
timeFrame: baseline to 24 hours
Secondary outcomes:
measure: duration of operation
timeFrame: 24 hour
measure: resistance to Laringeal mask placement (none, mild, moderate, severe)
timeFrame: 24 hours
measure: time taken for Laringeal mask placement (opening of the mouth for placement and time to confirmation of LMA placement with capnograph and auscultation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Bilkent
Study officials:
affiliation: Ankara City Hospital Bilkent
name: FERYAL AKÇAY
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara City Hospital Bilkent
name: FERYAL AKÇAY
role: STUDY_CHAIR
References: