Laryngeal Mask AirwayNCT07838051
Effect of Muscle Relaxants on Postoperative Sore Throat in Video Laryngeal Mask Airway(LMA) Use
An observational study of Laryngeal Mask Airway, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Video laryngeal masks (VLMAs) are increasingly used as a minimally invasive alternative in airway management. The use of neuromuscular blocking agents can affect VLMA placement and airway physiology. As a result, there may be differences in postoperative respiratory complications and middle ear pressure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laryngeal Mask Airway
- What is being tested?
- using rocuronium before vide laryngeal mask airway
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who will use a laryngeal mask in their surgical procedures
Who may be able to join
- Cases lasting longer than 1 hour
- Participants with body mass index >30
- Participants with ASA I, II, III
Who cannot join
- Participants with a body mass index < 30
- Pregnant women
- Participants with expected difficult airway passage
- Cases lasting less than 1 hour
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Samsun City Hospital
Samsun, Samsun, 55080
hatice selçuk kuşderci, +905052159896, drkusderci@hotmail.com
About this study
Official title: Effect of Muscle Relaxants on Postoperative Sore Throat in Video Video Laryngeal Mask Airway(LMA) Use: A Randomized Study
Video laryngeal masks (VLMAs) are increasingly used as a minimally invasive alternative in airway management. The use of neuromuscular blocking agents can affect VLMA placement and airway physiology. As a result, there may be differences in postoperative respiratory complications and middle ear pressure.
Read the detailed description
Video laryngeal masks (VLMAs) are frequently used in airway management. Especially in surgical procedures lasting longer than one hour, VLMA cuff pressure, positive pressure ventilation, and airway manipulations are associated with postoperative sore throat and changes in middle ear pressure. The aim of this study is to evaluate the effect of neuromuscular blocker (rocuronium) administration on postoperative sore throat during video laryngeal mask use in surgical procedures lasting longer than one hour. Furthermore, it aims to examine its effects on changes in middle ear pressure, oropharyngeal leak pressure, and airway-related clinical parameters.
- Conditions
- Laryngeal Mask Airway
- Being tested
- using rocuronium before vide laryngeal mask airway
- Keywords
- laryngeal mask airway, middle ear pressure, sore throat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using rocuronium before vide laryngeal mask airwayDrug
Also called rocuronium
using rocuronium before video laryngeal mask airway
| Study group | Role | What they receive |
|---|---|---|
| Group K | In this group, a video laryngeal mask will be implanted with the aid of a neuromuscular blocker. Receives: Drug: using rocuronium before vide laryngeal mask airway | |
| Group S | In this group, a video laryngeal mask will be placed without the use of neuromuscular blockers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative sore throat
Postoperative sore throat will be assessed using NRS (0: no pain, 10: most severe pain).
Measured: 24 hours
Secondary outcomes (3)
Changes in middle ear pressure
In this study, middle ear pressure will be assessed using tympanometry during the preoperative period, immediately after induction of anesthesia, following endotracheal intubation, and at the 3rd and 5th minutes thereafter.
Measured: 1 hour
Oropharyngeal leak pressure
Oropharyngeal leak pressure (OLP) was measured by closing the adjustable pressure-limiting (APL) valve with a fresh gas flow of 3 L/min, and the airway pressure at which an audible leak occurred or the manometer pressure reached a plateau was recorded as the OLP (cmH₂O).
Measured: during surgery
video laryngeal mask airway placement time
Video laryngeal mask airway placement time will be recorded after induction.
Measured: 2 minutes after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start4 May 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Mask AirwayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hatice selçuk kuşderci, Principal investigator, Samsun City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838051
- Sponsor's protocol ID
- GOKAEK 20225/25/33
- Status last verified
- May 2026
- First submitted
- 1 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscle Relaxants on Postoperative Sore Throat in Video Video Laryngeal Mask Airway(LMA) Use: A Randomized Study
- ClinicalTrials.gov ID
- NCT07838051
- Acronym / sponsor ID
- GOKAEK 20225/25/33
- Conditions
- Laryngeal Mask Airway
- Keywords
- laryngeal mask airway, middle ear pressure, sore throat
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Video laryngeal masks (VLMAs) are increasingly used as a minimally invasive alternative in airway management. The use of neuromuscular blocking agents can affect VLMA placement and airway physiology. As a result, there may be differences in postoperative respiratory complications and middle ear pressure.
Detailed description
Video laryngeal masks (VLMAs) are frequently used in airway management. Especially in surgical procedures lasting longer than one hour, VLMA cuff pressure, positive pressure ventilation, and airway manipulations are associated with postoperative sore throat and changes in middle ear pressure. The aim of this study is to evaluate the effect of neuromuscular blocker (rocuronium) administration on postoperative sore throat during video laryngeal mask use in surgical procedures lasting longer than one hour. Furthermore, it aims to examine its effects on changes in middle ear pressure, oropharyngeal leak pressure, and airway-related clinical parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group K | – | Drug: using rocuronium before vide laryngeal mask airwayIn this group, a video laryngeal mask will be implanted with the aid of a neuromuscular blocker. |
| Group S | – | –In this group, a video laryngeal mask will be placed without the use of neuromuscular blockers. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who will use a laryngeal mask in their surgical procedures
Key inclusion criteria (3 listed)
- Cases lasting longer than 1 hour
- Participants with body mass index >30
- Participants with ASA I, II, III
Key exclusion criteria (4 listed)
- Participants with a body mass index < 30
- Pregnant women
- Participants with expected difficult airway passage
- Cases lasting less than 1 hour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| using rocuronium before vide laryngeal mask airwayAlso: rocuroniumusing rocuronium before video laryngeal mask airway | Drug | Group K |
Primary outcome
Postoperative sore throat
Time frame: 24 hours
Postoperative sore throat will be assessed using NRS (0: no pain, 10: most severe pain).
3 secondary outcomes
Changes in middle ear pressure
Time frame: 1 hour
Oropharyngeal leak pressure
Time frame: during surgery
video laryngeal mask airway placement time
Time frame: 2 minutes after induction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Related trials for Laryngeal Mask Airway
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
RecruitingObservational study
The Effect of Ultrasonographic Airway Measurements and Anatomical Differences on Laryngeal Mask Placement in Young and Older Adults
Airway Management, Laryngeal Mask Airway Insertion Skill
Recruiting
Supraglottic Airway for Resuscitation in Preemies
Respiratory Failure, Premature Neonates
RecruitingPhase 4
The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial
Pediatric, Anesthesia Induction
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Clinical Performance of Laryseal Clear Versus Ambu Aura 40 Laryngeal Mask Airway for Preschool Children
Supraglottic Airway Devices, Laryseal Clear Laryngeal Mask
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
hatice selçuk kuşderci principal investigator
Samsun City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Mask Airway, run by Samsun University 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Selçuk Kuşderci (+905052159896, drkusderci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative sore throat (time frame: 24 hours). 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 2026; AzTrials last refreshed its copy on 8 Nov 2026.