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

Ankara City Hospital

Status: Unknown

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

Treatments: Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04910659

E1-19-124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

9. Uncontrolled hypertension

10. Uncontrolled diabetes, pheochrocytoma, thyroid dysfunction

11. Those who do not have the ability to read and sign the consent form

12. Patients with gastroesophageal reflux

13. History of any herbal medicine use

14. Patients who do not want to sign the consent form

15. 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

acupuncture

Active Comparator group

Description:

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

Treatment:

Other: acupuncture

false acupuncture

Sham Comparator group

Description:

P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds while laser acupuncture closed

Treatment:

Other: acupuncture