Clinical trial NCT03614598: Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation
Official title: Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharyngolaryngeal Postoperative Pain
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Incidence of pharyngolaryngeal postoperative pain of the three devices
timeFrame: 24 hours
Secondary outcomes:
measure: Pharyngolaryngeal postoperative pain between groups
timeFrame: 2 hours
measure: Time taken to place device
timeFrame: End of surgery (maximum 2 hours)
measure: Number of attempts needed to place device
timeFrame: End of surgery (maximum 2 hours)
measure: Necessity of altering the size of the device
timeFrame: End of surgery (maximum 2 hours)
measure: Any patient movement during procedure
timeFrame: End of surgery (maximum 2 hours)
measure: Difficulty of insertion
timeFrame: End of surgery (maximum 2 hours)
measure: Total leakage pressure of the devices
timeFrame: End of surgery (maximum 2 hours)
measure: Ventilatory pressure of the devices
timeFrame: End of surgery (maximum 2 hours)
measure: Device stability during surgery
timeFrame: End of surgery (maximum 2 hours)
measure: Difficulty of device removal
timeFrame: End of surgery (maximum 2 hours)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Joël L'Hermite, MD
role: PRINCIPAL_INVESTIGATOR
References: