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

NCT04910659 | Unknown

• 1 other identifier: E1-19-124
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; Laryngeal Mask Airway; Pain, Postoperative; Sore Throat

Keywords

Sore Throat; Laryngeal Mask Airway; Acupuncture

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• duration of operation

  24 hour

• resistance to Laringeal mask placement (none, mild, moderate, 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

  24 hours

Study Arms (2)

acupuncture

ACTIVE COMPARATOR

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

false acupuncture

SHAM COMPARATOR

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

Interventions

acupuncture OTHER

P6, LI4 and LI 11 stimulation

acupuncture; false acupuncture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who recieved general anesthesia with LMA
• surgery duration \< 2 hours
• between 18-60 years of age
• ASA1-2 scores

You may not qualify if:

• 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
• \. Uncontrolled hypertension
• \. Uncontrolled diabetes, pheochrocytoma, thyroid dysfunction
• \. Those who do not have the ability to read and sign the consent form
• \. Patients with gastroesophageal reflux
• \. History of any herbal medicine use
• \. Patients who do not want to sign the consent form
• \. Patients with difficult LMA placement

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Pharyngitis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• FERYAL AKÇAY

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

• FERYAL AKÇAY

  Ankara City Hospital Bilkent

  STUDY CHAIR

Central Study Contacts

FERYAL AKÇAY

CONTACT

+905459735654; feryalkakcay@gmail.com

TUNAHAN ÇEVİK

CONTACT

+905459735654; drtunahanceviknumune@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized controlled study

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: June 2, 2021
• Study Start: January 1, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 30, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-03

Locations

TU (1)