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

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Pharyngolaryngeal Postoperative Pain

Treatments

Procedure: Insertion of I-GEL(R) device
Procedure: Insertion of LMA-SUPREME(TM) device
Procedure: Insertion of LMA-UNIQUE(TM) device

Study type

Interventional

Funder types

Other

Identifiers

NCT03614598
Local/2008/JL- 02

Details and patient eligibility

About

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

Enrollment

546 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

546 participants in 3 patient groups

LMA-UNIQUE™
Active Comparator group
Treatment:
Procedure: Insertion of LMA-UNIQUE(TM) device
LMA-SUPREME™
Active Comparator group
Treatment:
Procedure: Insertion of LMA-SUPREME(TM) device
I-GEL®
Active Comparator group
Treatment:
Procedure: Insertion of I-GEL(R) device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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