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

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

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

Conditions
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Pharyngolaryngeal Postoperative Pain

Intervention / Treatment
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* Procedure: Insertion of LMA-UNIQUE(TM) device
* Procedure: Insertion of LMA-SUPREME(TM) device
* Procedure: Insertion of I-GEL(R) device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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) |