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Completed

NCT Number: NCT03614598

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

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

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Key information

Conditions

Pharyngolaryngeal Postoperative Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insertion of LMA-UNIQUE(TM) device

Procedure

LMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

Insertion of LMA-SUPREME(TM) device

Procedure

LMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

Insertion of I-GEL(R) device

Procedure

I-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation

Primary outcomes

  1. Incidence of pharyngolaryngeal postoperative pain of the three devices

    Time frame: 24 hours

    Sore throat Y/N

Secondary outcomes

  1. Pharyngolaryngeal postoperative pain between groups

    Time frame: 2 hours

    Sore throat Y/N

  2. 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)

  3. Number of attempts needed to place device

    Time frame: End of surgery (maximum 2 hours)

  4. Necessity of altering the size of the device

    Time frame: End of surgery (maximum 2 hours)

    Y/N

  5. Any patient movement during procedure

    Time frame: End of surgery (maximum 2 hours)

    Y/N

  6. Difficulty of insertion

    Time frame: End of surgery (maximum 2 hours)

    5-point scale: very easy-failure

  7. Total leakage pressure of the devices

    Time frame: End of surgery (maximum 2 hours)

    measured directly by the respirator

  8. Ventilatory pressure of the devices

    Time frame: End of surgery (maximum 2 hours)

  9. 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

  10. Difficulty of device removal

    Time frame: End of surgery (maximum 2 hours)

    4-point scale: very easy-very difficult

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: DISPOSITIF LAR

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 3, 2018
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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