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

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

Study Overview

• Status: Completed
• Conditions: Pharyngolaryngeal Postoperative Pain
• Intervention / Treatment: Procedure: Insertion of LMA-UNIQUE(TM) device; Procedure: Insertion of LMA-SUPREME(TM) device; Procedure: Insertion of I-GEL(R) device

• Study Type: Interventional
• Enrollment (Actual): 546
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LMA-UNIQUE™	Procedure: Insertion of LMA-UNIQUE(TM) device; LMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
Active Comparator: LMA-SUPREME™	Procedure: Insertion of LMA-SUPREME(TM) device; LMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
Active Comparator: I-GEL®	Procedure: Insertion of I-GEL(R) device; I-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pharyngolaryngeal postoperative pain of the three devices	Sore throat Y/N	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Joël L'Hermite, MD, CHU Nimes

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2009
• Primary Completion (Actual): September 5, 2012
• Study Completion (Actual): September 6, 2012

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Local/2008/JL- 02; 2008-A00741-54 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No