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

NCT03614598 | Completed

• 2 other identifiers: Local/2008/JL- 022008-A00741-54
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharyngolaryngeal Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of pharyngolaryngeal postoperative pain of the three devices

  Sore throat Y/N

  24 hours

Secondary Outcomes (10)

• Pharyngolaryngeal postoperative pain between groups

  2 hours

• Time taken to place device

  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

  End of surgery (maximum 2 hours)

• Any patient movement during procedure

  End of surgery (maximum 2 hours)

Study Arms (3)

LMA-UNIQUE™

ACTIVE COMPARATOR

Procedure: Insertion of LMA-UNIQUE(TM) device

LMA-SUPREME™

ACTIVE COMPARATOR

Procedure: Insertion of LMA-SUPREME(TM) device

I-GEL®

ACTIVE COMPARATOR

Procedure: Insertion of I-GEL(R) device

Interventions

Insertion of LMA-UNIQUE(TM) device PROCEDURE

LMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

LMA-UNIQUE™

Insertion of LMA-SUPREME(TM) device PROCEDURE

LMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

LMA-SUPREME™

Insertion of I-GEL(R) device PROCEDURE

I-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

I-GEL®

Eligibility Criteria

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

You may qualify if:

• 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 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 27755181 RESULT

Study Officials

• Joël L'Hermite, MD

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 3, 2018
• Study Start: April 22, 2009
• Primary Completion: September 5, 2012
• Study Completion: September 6, 2012
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1)