Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation (NCT03614598)

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Study summary

The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5%

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Conditions studied

Pharyngolaryngeal Postoperative Pain

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In context

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
Adult patients > 18
ASA score I-III
Patient scheduled to undergo elective surgery lasting less than two hours under general anaesthetic without tracheal intubation
The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
The subject refuses to sign the consent
It is impossible to give the subject informed information
The patient is under safeguard of justice or state guardianship
The patient is pregnant or breastfeeding
Emergency surgery
Sore thoat ≤ 1 month
Risk of aspiration of gastric contents
Body mass index (BMI) > 35
Patients with expected airway difficulties
Contra-indication for any of the devices (symptomatic hiatal hernias, pathological obesity, poly trauma or serious injury, delayed gastric emptying, use of opiates during fasting)
Patients who are not fasting for routine and emergency anesthesia
Trismus, limited mouth opening, abscess or pharyngoperilaryngeal mass

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Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Outcomes assessor)
Enrollment: 546 participants (actual)

Study arms

Active comparator
LMA-UNIQUE™
Procedure: Insertion of LMA-UNIQUE(TM) device
Active comparator
LMA-SUPREME™
Procedure: Insertion of LMA-SUPREME(TM) device
Active comparator
I-GEL®
Procedure: Insertion of I-GEL(R) device

Interventions

ProcedureInsertion of LMA-UNIQUE(TM) device
LMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
ProcedureInsertion of LMA-SUPREME(TM) device
LMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
ProcedureInsertion of I-GEL(R) device
I-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

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What researchers measure

Primary outcomes

Incidence of pharyngolaryngeal postoperative pain of the three devices
Sore throat Y/N
Time frame: 24 hours

Secondary outcomes

Pharyngolaryngeal postoperative pain between groups
Sore throat Y/N
Time frame: 2 hours
Time taken to place device
From first attempt at introduction until acceptable exhaled CO2 curve attained (seconds)
Time frame: End of surgery (maximum 2 hours)
Number of attempts needed to place device
Time frame: End of surgery (maximum 2 hours)
Necessity of altering the size of the device
Y/N
Time frame: End of surgery (maximum 2 hours)
Any patient movement during procedure
Y/N
Time frame: End of surgery (maximum 2 hours)
Difficulty of insertion
5-point scale: very easy-failure
Time frame: End of surgery (maximum 2 hours)
Total leakage pressure of the devices
measured directly by the respirator
Time frame: End of surgery (maximum 2 hours)
Ventilatory pressure of the devices
Time frame: End of surgery (maximum 2 hours)
Device stability during surgery
Need to change the management system airways (orotracheal intubation or others) Y/N
Time frame: End of surgery (maximum 2 hours)
Difficulty of device removal
4-point scale: very easy-very difficult
Time frame: End of surgery (maximum 2 hours)

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Study locations

1 site

CHU Nimes
Nîmes, 30029, France

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References and documents

Publications

L'Hermite J, Dubout E, Bouvet S, Bracoud LH, Cuvillon P, Coussaye JE, Ripart J. Sore throat following three adult supraglottic airway devices: A randomised controlled trial. Eur J Anaesthesiol. 2017 Jul;34(7):417-424. doi: 10.1097/EJA.0000000000000539. PubMed 27755181 ↗

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Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID: NCT03614598
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Responsible party: Sponsor
First posted: Aug 3, 2018
Start date: Apr 22, 2009
Primary completion: Sep 5, 2012
Completion: Sep 6, 2012
Last update: Nov 17, 2025

Study contacts

Joël L'Hermite, MD

principal investigator · CHU Nimes

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation

From the registry’s dates