NCT04910659

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

June 8, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

March 30, 2021

Last Update Submit

June 3, 2021

Conditions

AcupunctureLaryngeal Mask AirwayPain, PostoperativeSore Throat

Keywords

Sore ThroatLaryngeal Mask AirwayAcupuncture

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

acupunctureOTHER

P6, LI4 and LI 11 stimulation

acupuncturefalse acupuncture

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePharyngitis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • FERYAL AKÇAY

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

  • FERYAL AKÇAY

    Ankara City Hospital Bilkent

    STUDY CHAIR

Central Study Contacts

FERYAL AKÇAY

CONTACT

+905459735654feryalkakcay@gmail.com

TUNAHAN ÇEVİK

CONTACT

+905459735654drtunahanceviknumune@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
Model Details: prospective randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

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)