- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04910659
Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
Effectiveness of Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: FERYAL AKÇAY
- Phone Number: +905459735654
- Email: feryalkakcay@gmail.com
Study Contact Backup
- Name: TUNAHAN ÇEVİK
- Phone Number: +905459735654
- Email: drtunahanceviknumune@gmail.com
Study Locations
-
-
-
Ankara, Turkey
- Recruiting
- Ankara City Hospital Bilkent
-
Contact:
- Feryal Akçay
- Phone Number: +905459735654
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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
Study Plan
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
|
|
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
Sponsor
Investigators
- Principal Investigator: FERYAL AKÇAY, Ankara City Hospital Bilkent
- Study Chair: FERYAL AKÇAY, Ankara City Hospital Bilkent
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E1-19-124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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