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

June 3, 2021 updated by: Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Ankara, Turkey
        • Recruiting
        • Ankara City Hospital Bilkent
        • Contact:
          • Feryal Akçay
          • Phone Number: +905459735654

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: acupuncture
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
P6, LI4 and LI 11 stimulation
SHAM_COMPARATOR: false acupuncture
P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds while laser acupuncture closed
P6, LI4 and LI 11 stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline sore throat at 24 h
Time Frame: baseline to 24 hours
postoperative sore throat is evaluated at 0th, 2th, 6th, 12th, 24th hours with using no, mild, moderate, severe scale.
baseline to 24 hours
Change from Baseline postoperative cough at 24 hours
Time Frame: baseline to 24 hours
postoperative cough is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
baseline to 24 hours
Change from Baseline postoperative snoring at 24 hours
Time Frame: baseline to 24 hours
postoperative snoring is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
baseline to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of operation
Time Frame: 24 hour
24 hour
resistance to Laringeal mask placement (none, mild, moderate, severe)
Time Frame: 24 hours
  1. none
  2. mild
  3. moderate
  4. severe
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 Frame: 24 hours
time from opening of the mouth for placement to confirmation of LMA placement with capnograph and auscultation
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: FERYAL AKÇAY, Ankara City Hospital Bilkent
  • Study Chair: FERYAL AKÇAY, Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

July 15, 2021

Study Completion (ANTICIPATED)

July 30, 2021

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

May 31, 2021

First Posted (ACTUAL)

June 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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