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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: September 5, 2012

Interventions

  • Procedure: Insertion of LMA-UNIQUE(TM) device
    • LMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
  • Procedure: Insertion of LMA-SUPREME(TM) device
    • LMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
  • Procedure: Insertion of I-GEL(R) device
    • I-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

Arms, Groups and Cohorts

  • Active Comparator: LMA-UNIQUE™
  • Active Comparator: LMA-SUPREME™
  • Active Comparator: I-GEL®

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of pharyngolaryngeal postoperative pain of the three devices
    • Time Frame: 24 hours
    • Sore throat Y/N

Secondary Measures

  • Pharyngolaryngeal postoperative pain between groups
    • Time Frame: 2 hours
    • Sore throat Y/N
  • Time taken to place device
    • Time Frame: 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
    • Time Frame: End of surgery (maximum 2 hours)
  • Necessity of altering the size of the device
    • Time Frame: End of surgery (maximum 2 hours)
    • Y/N
  • Any patient movement during procedure
    • Time Frame: End of surgery (maximum 2 hours)
    • Y/N
  • Difficulty of insertion
    • Time Frame: End of surgery (maximum 2 hours)
    • 5-point scale: very easy-failure
  • Total leakage pressure of the devices
    • Time Frame: End of surgery (maximum 2 hours)
    • measured directly by the respirator
  • Ventilatory pressure of the devices
    • Time Frame: End of surgery (maximum 2 hours)
  • Device stability during surgery
    • Time Frame: End of surgery (maximum 2 hours)
    • Need to change the management system airways (orotracheal intubation or others) Y/N
  • Difficulty of device removal
    • Time Frame: End of surgery (maximum 2 hours)
    • 4-point scale: very easy-very difficult

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nīmes
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joël L’Hermite, MD, Principal Investigator, CHU Nimes

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