Clinical trial NCT02322502: Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia
Official title: Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia: a Randomized Multicenter Controlled Trial (ACC Baxter)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia With Use of LMA (Laryngeal Mask Airway)
Keywords: laryngeal mask airway
desflurane
sevoflurane
propofol
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: time of emergence from anesthesia
timeFrame: up to 15 minutes
Secondary outcomes:
measure: Airway reactions (Incidence of intraoperative coughs, laryngospasm)
timeFrame: up to 2 hours
measure: Emergence times
timeFrame: up to 15 minutes
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen University; Department of Anesthesia
city: Halle
country: Germany
facility: Martha-Maria Hospital Halle Dölau gGmbH, Department of Anesthesia
city: Reutlingen
country: Germany
facility: Kreiskliniken Reutlingen, Department of Anesthesia
city: Ulm
country: Germany
facility: University Hospital Ulm, Department of Anesthesia
Study officials:
affiliation: University Hospital, Aachen
name: Mark Coburn, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kowark A, Rossaint R, Puhringer F, Keszei AP, Fritz H, Froba G, Rex C, Haas H, Otto V, Coburn M; Study Collaborators. Emergence times and airway reactions during general anaesthesia with remifentanil and a laryngeal mask airway: A multicentre randomised controlled trial. Eur J Anaesthesiol. 2018 Aug;35(8):588-597. doi: 10.1097/EJA.0000000000000852.
citation: Stevanovic A, Rossaint R, Keszei AP, Fritz H, Froba G, Puhringer F, Coburn M. Emergence times and airway reactions in general laryngeal mask airway anesthesia: study protocol for a randomized controlled trial. Trials. 2015 Jul 26;16:316. doi: 10.1186/s13063-015-0855-2.