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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04910659
• Other study ID #: E1-19-124
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: March 2021
• Source: Ankara City Hospital Bilkent
• Contact: FERYAL AKÇAY
• Phone: +905459735654
• Email: feryalkakcay[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 30, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acupuncture
• Laryngeal Mask Airway
• Pain, Postoperative
• Pharyngitis
• Sore Throat

Intervention

Other:
• acupuncture
P6, LI4 and LI 11 stimulation

Locations

Country	Name	City	State
Turkey	Ankara City Hospital Bilkent	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	duration of operation		24 hour
Secondary	resistance to Laringeal mask placement (none, mild, moderate, severe)	none; mild; moderate; severe	24 hours
Secondary	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