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

Primary Purpose

Acupuncture, Laryngeal Mask Airway, Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acupuncture focused on measuring Sore Throat, Laryngeal Mask Airway, Acupuncture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Ankara City Hospital BilkentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

acupuncture

false acupuncture

Arm 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

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

Outcomes

Primary Outcome Measures

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.
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
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

Secondary Outcome Measures

duration of operation
resistance to Laringeal mask placement (none, mild, moderate, severe)
none mild moderate severe
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

Full Information

First Posted
March 30, 2021
Last Updated
June 3, 2021
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT04910659
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 15, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Laryngeal Mask Airway, Pain, Postoperative, Sore Throat
Keywords
Sore Throat, Laryngeal Mask Airway, Acupuncture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled study
Masking
ParticipantOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acupuncture
Arm Type
Active Comparator
Arm 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
Arm Title
false acupuncture
Arm Type
Sham Comparator
Arm Description
P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds while laser acupuncture closed
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
P6, LI4 and LI 11 stimulation
Primary Outcome Measure Information:
Title
Change from Baseline sore throat at 24 h
Description
postoperative sore throat is evaluated at 0th, 2th, 6th, 12th, 24th hours with using no, mild, moderate, severe scale.
Time Frame
baseline to 24 hours
Title
Change from Baseline postoperative cough at 24 hours
Description
postoperative cough is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
Time Frame
baseline to 24 hours
Title
Change from Baseline postoperative snoring at 24 hours
Description
postoperative snoring is evaluated at 0th, 2th, 6th, 12th, 24th hours and recorded as present or absent
Time Frame
baseline to 24 hours
Secondary Outcome Measure Information:
Title
duration of operation
Time Frame
24 hour
Title
resistance to Laringeal mask placement (none, mild, moderate, severe)
Description
none mild moderate severe
Time Frame
24 hours
Title
time taken for Laringeal mask placement (opening of the mouth for placement and time to confirmation of LMA placement with capnograph and auscultation
Description
time from opening of the mouth for placement to confirmation of LMA placement with capnograph and auscultation
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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: Being younger than 18 years old or being over the age of 60 Patients with an ASA score of 3 and greater than 3 Active infections in the area to be acupuncture. Prolonged bleeding time Liver failure Renal insufficiency Pregnancy 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FERYAL AKÇAY
Phone
+905459735654
Email
feryalkakcay@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
TUNAHAN ÇEVİK
Phone
+905459735654
Email
drtunahanceviknumune@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FERYAL AKÇAY
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
FERYAL AKÇAY
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara City Hospital Bilkent
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feryal Akçay
Phone
+905459735654

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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