Insertion of Laryngeal Mask Airways and Postoperative Sore Throat

NCT06713343 | Completed

• 1 other identifier: LMA and Sore Throat
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

When the instruction guidelines of classical laryngeal mask airways (cLMAs) were examined, it was seen that they should be stored between 10 °C and 25 °C. The purpose of this study is to test the effect on postoperative sore throat of LMA stored at different temperatures. The patients to be admitted for elective surgery will be divided into two groups. Patients in Group L will be ventilated with a classical laryngeal mask airways (cLMA) stored at 10 °C to 12 °C (low temperatures), while patients in Group R will be ventilated with a classical laryngeal mask airways (cLMA) stored at 22 °C to 25 °C (room temperatures). Postoperative complaints of sore throat, dysphagia, dysphonia and cough at 0, 1, 6, 12 and 24 hours will be questioned and noted.

Conditions

General Anesthesia; Laryngeal Mask Airways; Postoperative Sore Throat; Insertion of LMA

Keywords

laryngeal mask airway; postoperative sore throat; LMA

Outcome Measures

Primary Outcomes (1)

• Postoperative Sore Throat

  Postoperative sore throat will be evaluated according to the Numeric Rating Scale (NRS) pain score. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which the patient rates the pain from 0 (no pain) to 10 (worst pain imaginable).

  Sore throat at postoperatively 0, 1, 6, 12 and 24 hours will be questioned and noted.

Secondary Outcomes (2)

• Postoperative Dysphagia, Cough and Dysphonia

  Dysphagia, cough and dysphonia at postoperatively 0, 1, 6, 12 and 24 hours will be questioned and noted.

• Ease of application of laryngeal mask airways

  The duration from opening of mouth for placement until confirmation of laryngeal mask airways placement by capnograph will be measured, within 5 minutes.

Study Arms (2)

Group L

ACTIVE COMPARATOR

Patients in Group L will be ventilated with a classical laryngeal mask (cLMA) stored at 10 °C to 12 °C (low temperatures)

Device: Laryngeal Mask Airways

Group R

ACTIVE COMPARATOR

Patients in Group R will be ventilated with a classical laryngeal mask (cLMA) stored at 22 °C to 25 °C (room temperatures)

Device: Laryngeal Mask Airways

Interventions

Laryngeal Mask Airways DEVICE

The 172 patients who will be admitted for elective surgery will be divided into two groups as Group L and Group R by computer-assisted randomization method. Patients in Group L will be ventilated with a classical laryngeal mask airways (cLMA) stored at 10 °C to 12 °C (low temperatures), while patients in Group R will be ventilated with a classical laryngeal mask airways (cLMA) stored at 22 °C to 25 °C (room temperatures).

Group L; Group R

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Under elective conditions, between 18-65 years of age, those who will receive general anesthesia and ventilation will be provided with a laryngeal mask airways
• ASA I-III risk group
• Patients who agreed to be included in the study
• Estimated duration of anesthesia lasting between 1 hour and 2 hours

You may not qualify if:

• Patients younger than 18 and older than 65 years old
• Patients who are incapable of reading, understanding and signing the consent form
• Hemodynamically unstable patients
• Patients with orofacial clefts or abnormalities of the oral cavity or pharynx, patients who have undergone oral or laryngeal surgery
• Patients at high risk of aspiration of gastric contents (pregnant women, those with gastro-esophageal reflux, those with hiatal hernia)
• Patients do not want to participate in the study
• Patients with sore throat in the last 30 days before surgeryPatients
• Patients with advanced dementia
• Patients with ASA score above III
• Patients with a Mallampati score of 4
• Emergency surgical procedures

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: December 3, 2024
• Study Start: November 11, 2024
• Primary Completion: January 30, 2025
• Study Completion: February 3, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)