Pharyngolaryngeal Postoperative Pain
Conditions
Brief summary
The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5%
Interventions
PROCEDUREInsertion of LMA-UNIQUE(TM) device
LMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
PROCEDUREInsertion of LMA-SUPREME(TM) device
LMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
PROCEDUREInsertion of I-GEL(R) device
I-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pharyngolaryngeal postoperative pain of the three devices | 24 hours | Sore throat Y/N |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time taken to place device | End of surgery (maximum 2 hours) | From first attempt at introduction until acceptable exhaled CO2 curve attained (seconds) |
| 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) | Y/N |
| Any patient movement during procedure | End of surgery (maximum 2 hours) | Y/N |
| Pharyngolaryngeal postoperative pain between groups | 2 hours | Sore throat Y/N |
| Total leakage pressure of the devices | End of surgery (maximum 2 hours) | measured directly by the respirator |
| Ventilatory pressure of the devices | End of surgery (maximum 2 hours) | — |
| Device stability during surgery | End of surgery (maximum 2 hours) | Need to change the management system airways (orotracheal intubation or others) Y/N |
| Difficulty of device removal | End of surgery (maximum 2 hours) | 4-point scale: very easy-very difficult |
| Difficulty of insertion | End of surgery (maximum 2 hours) | 5-point scale: very easy-failure |
Countries
France
Outcome results
None listed