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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04910659
Other study ID # E1-19-124
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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