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Completed

NCT Number: NCT02322502

Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia

The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia.

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Key information

Conditions

Anesthesia With Use of LMA (Laryngeal Mask Airway)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

RWTH Aachen University; Department of Anesthesia, Aachen, Germany

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About this study

The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia (stating the date of birth) and second if desflurane is non-inferior in the occurrence of airway complications compared to sevoflurane or total intravenous anesthesia with propofol in the setting of laryngeal mask airway.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Planned anesthesia with use of LMA (laryngeal mask airway)
  • Planned duration of anesthesia between 0.5 and 2 hours
  • Age between 18-75 years
  • Both gender
  • Body mass index (BMI) <35
  • ASA 1-3
  • Written informed consent prior to study participation

Exclusion criteria

  • Planned additional regional and local anesthesia
  • Contra-indication for the use of a laryngeal mask airway
  • Asthma
  • COPD IV
  • Known allergy or hypersensitivity to any drugs administered during this study
  • Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods
  • Participation in a drug or device trial within the previous 30 days.
  • Patients legally unable to give written informed consent.
  • Patients with severe psychiatric disorders
  • Recent (<6 months) history of alcohol or drug abuse
  • Patients with severe neuropsychiatric disorders
  • Non-fluency in German language

Treatment and study plan

Desflurane

Drug

inhalation with laryngeal mask to maintain anaesthesia

Other names: Suprane

Sevoflurane

Drug

inhalation with laryngeal mask to maintain anaesthesia

Other names: Sevorane

Propofol

Drug

intravenous injection to maintain anaesthesia

Other names: Anesia

Primary outcomes

  1. time of emergence from anesthesia

    Time frame: up to 15 minutes

    time of emergence from anesthesia defined as time between cessation of anesthesia until patient is able to state his/her date of birth on command

Secondary outcomes

  1. Airway reactions (Incidence of intraoperative coughs, laryngospasm)

    Time frame: up to 2 hours

    Incidence of intraoperative coughs (induction/maintenance) - non-inferiority design Incidence of intraoperative laryngospasm (induction/maintenance) Incidence of cough at emergence Incidence of laryngospasms at emergence

  2. Emergence times

    Time frame: up to 15 minutes

    Time to remove laryngeal mask Time to open eyes on command Time to respond on command (press hand) Time to state the name on command Recovery Index (RI = 1 + Aldrete5min/[(2xextubation time) + 1 x opening eyes time)]

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia: a Randomized Multicenter Controlled Trial (ACC Baxter)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2014
Registry last updated
Oct 6, 2016

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.