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

Not Applicable

Completed

• Conditions: Pharyngolaryngeal Postoperative Pain
• Interventions: Procedure: Insertion of LMA-UNIQUE(TM) device; Procedure: Insertion of LMA-SUPREME(TM) device; Procedure: Insertion of I-GEL(R) device

• Registration Number: NCT03614598
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-22
• Primary Completion: 2012-09-05
• Study Completion: 2012-09-05
• Status Verified: 2018-07
• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-07-30
• Last Update Submitted: 2018-07-30
• Study First Posted: 2018-08-03
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 546

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA-UNIQUE™	Insertion of LMA-UNIQUE(TM) device	-
LMA-SUPREME™	Insertion of LMA-SUPREME(TM) device	-
I-GEL®	Insertion of I-GEL(R) device	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France