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General AnesthesiaNCT06713343

Insertion of Laryngeal Mask Airways and Postoperative Sore Throat

A study testing Laryngeal Mask Airways in people with General Anesthesia and Laryngeal Mask Airways, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Laryngeal Mask Airways
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteTurkey (Türkiye)
Study dates
11 Nov 2024to 3 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital

    Ankara, Çankaya, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effect on Postoperative Sore Throat of Insertion of Laryngeal Mask Airways Stored at Different Temperatures

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.

Read the detailed description

Under elective conditions, estimated 172 patients between 18 and 65 years of age who will receive general anesthesia and ventilation with laryngeal mask airways (LMA) and the duration of anesthesia will last more than 1 hour and less than 2 hours will be included in the study. The study will be designed as a prospective, randomized, controlled study. 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). Patients will be routinely evaluated preoperatively and written informed consent will be taken. Patients' age, gender, weight, height, BMI (body mass index), comorbidities, regular medications, type of surgery, ASA (American Society of Anesthesiologists) physical status and mallampati score will be recorded in the preoperative waiting area. When patients are admitted to the operating room, non-invasive arterial blood pressure monitoring, 3 or 5-channel ECG and pulse oximetry monitoring will be performed in the standard working order of the anesthesia clinic. Hemodynamic parameters; heart rate (HR)(beats/minute), systolic arterial blood pressure (SBP)(mmHg), diastolic arterial blood pressure (DBP)(mmHg), mean arterial blood pressure (MAP)(mmHg) and peripheral oxygen saturation (SpO2) will be recorded at 0, 5, 10, 15, 30, 60, 90, and 120 minutes. After preoxygenation (100% oxygen with balloon and mask for 3 minutes), anesthesia induction will be performed with midazolam 0.02 mg/kg, fentanyl 2 mcg/kg, lidocaine 1 mg/kg and propofol 2mg/kg in both groups. 90 seconds after induction, 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). In both groups, The cLMA will be inserted by an anesthesiologist who has at least 3 years of experience. No lubricant material will be applied to the cLMA. The cLMA size of both groups will be decided according to the weight of the patients. For cLMA, LMAs will be applied as NO 3: 30-50 kg, NO 4: 50-70 kg, NO 5: >70 kg. After placement of the cLMA, it will be inflated with air until the maximum recommended volume is reached and no leakage sound is heard, and the maximum cuff pressure will be 60 cmH20. The time of LMA insertion, resistance to LMA insertion (none, mild, moderate, severe), time to LMA insertion (time from opening the mouth for insertion until confirmation of LMA insertion by capnograph) and time of LMA cuff inflation will be noted on the patient evaluation form. Anesthesia will be maintained with sevoflurane and remifentanyl infusion. For postoperative pain, 1 mg/kg tramadol will be administered to both groups 15 minutes before the end of surgery as an infusion in 150 ml isotonic saline solution to be completed in 30 minutes. After the operation, when the patient starts breathing spontaneously, the LMA will be removed and oral secretions will be gently aspirated with a 14 F (French) soft aspiration catheter. The time of LMA removal, the duration of positive pressure ventilation, the duration of surgery, whether there was bleeding during the cleaning of oral secretions, whether there was blood on the LMA after LMA removal will be noted on the patient evaluation form. After the patients recover in the operating room, they will be transferred to the postoperative recovery room. Patients will be observed in the recovery room for 1 hour in the postoperative period. Patients will be asked about complaints of sore throat, dysphagia, dysphonia and cough at the 0th hour and 1st hour in the recovery room. Assessment of sore throat will be based on NRS (numeric rating scale) pain score. Dysphagia, dysphonia and cough complaints will be noted as present or absent. Patients will be sent to the services at the end of the 1st hour. Complaints of sore throat, dysphagia, dysphonia and cough at postoperatively 6, 12 and 24 hours will be questioned and noted.

Being tested
Laryngeal Mask Airways
Keywords
laryngeal mask airway, postoperative sore throat, LMA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laryngeal Mask AirwaysDevice

    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).

Study groups in NCT06713343
Study groupRoleWhat they receive
Group LActive comparatorPatients in Group L will be ventilated with a classical laryngeal mask (cLMA) stored at 10 °C to 12 °C (low temperatures)
Receives: Device: Laryngeal Mask Airways
Group RActive comparatorPatients in Group R will be ventilated with a classical laryngeal mask (cLMA) stored at 22 °C to 25 °C (room temperatures)
Receives: Device: Laryngeal Mask Airways

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (2)
  1. Postoperative Dysphagia, Cough and Dysphonia

    Postoperative dysphagia, cough and dysphonia will be assessed as present or absent.

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

  2. Ease of application of laryngeal mask airways

    The resistance encountered by the practitioner during LMA insertion will be noted as absent, mild, moderate and severe. The number of attempts to place LMA will be noted. Also, the duration from opening of the mouth for placement until confirmation of LMA placement by capnograph will be kept and noted. By comparing the resistance, the attempts and the duration between the two groups, ease of application of LMA will be assessed.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2024
  2. Study start11 Nov 2024
  3. Primary completion30 Jan 2025
  4. Study completion3 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06713343
Sponsor's protocol ID
LMA and Sore Throat
Status last verified
Feb 2025
First submitted
7 Nov 2024
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Laryngeal Mask Airways in people with General Anesthesia and Laryngeal Mask Airways, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Sore Throat (time frame: Sore throat at postoperatively 0, 1, 6, 12 and 24 hours will be questioned and noted.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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