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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acupuncture Laryngeal Mask Airway Pain, Postoperative Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized controlled study

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

double blind

Study Groups

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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

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type OTHER

P6, LI4 and LI 11 stimulation

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

Group Type SHAM_COMPARATOR

acupuncture

Intervention Type OTHER

P6, LI4 and LI 11 stimulation

Interventions

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acupuncture

P6, LI4 and LI 11 stimulation

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No