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

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ClinicalTrials.gov Identifier: NCT04910659
Recruitment Status : Recruiting
First Posted : June 2, 2021
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Ankara City Hospital Bilkent

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.

Condition or disease Intervention/treatment Phase
Acupuncture Laryngeal Mask Airway Pain, Postoperative Sore Throat Other: acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomized controlled study
Masking: Double (Participant, Outcomes Assessor)
Masking Description: double blind
Primary Purpose: Prevention
Official Title: Effectiveness of Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


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
Other: acupuncture
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
Other: acupuncture
P6, LI4 and LI 11 stimulation




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Secondary Outcome Measures :
  1. duration of operation [ Time Frame: 24 hour ]
  2. resistance to Laringeal mask placement (none, mild, moderate, severe) [ Time Frame: 24 hours ]
    1. none
    2. mild
    3. moderate
    4. severe

  3. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04910659


Contacts
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Contact: FERYAL AKÇAY +905459735654 feryalkakcay@gmail.com
Contact: TUNAHAN ÇEVİK +905459735654 drtunahanceviknumune@gmail.com

Locations
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Turkey
Ankara City Hospital Bilkent Recruiting
Ankara, Turkey
Contact: Feryal Akçay    +905459735654      
Sponsors and Collaborators
Ankara City Hospital Bilkent
Investigators
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Principal Investigator: FERYAL AKÇAY Ankara City Hospital Bilkent
Study Chair: FERYAL AKÇAY Ankara City Hospital Bilkent
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Responsible Party: Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier: NCT04910659    
Other Study ID Numbers: E1-19-124
First Posted: June 2, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ankara City Hospital Bilkent:
Sore Throat
Laryngeal Mask Airway
Acupuncture
Additional relevant MeSH terms:
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Pharyngitis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases