Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia With Use of LMA (Laryngeal Mask Airway)
• Intervention / Treatment: Drug: Desflurane; Drug: Sevoflurane; Drug: propofol

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.

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, D-52074
    • RWTH Aachen University; Department of Anesthesia
  • Halle, Germany, 06120
    • Martha-Maria Hospital Halle Dölau gGmbH, Department of Anesthesia
  • Reutlingen, Germany, 73764
    • Kreiskliniken Reutlingen, Department of Anesthesia
  • Ulm, Germany, 89075
    • University Hospital Ulm, Department of Anesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: desflurane; Suprane® Dose: 0.8 MAC / 4-5 vol. % Mode of administration: inhalation with laryngeal mask One application	Drug: Desflurane; inhalation with laryngeal mask to maintain anaesthesia; Other Names: Suprane
Active Comparator: sevoflurane; Sevoflurane: Dose: 0.8 MAC / 1.2-1.4 vol.% Mode of administration: inhalation with laryngeal mask One application	Drug: Sevoflurane; inhalation with laryngeal mask to maintain anaesthesia; Other Names: Sevorane
Active Comparator: propofol; Propofol Dose: 5-7 mg kg-1 h-1 to maintain a BIS index value between 40 and 60 Mode of administration: intravenous One application	Drug: propofol; intravenous injection to maintain anaesthesia; Other Names: Anesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of emergence from anesthesia	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	up to 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway reactions (Incidence of intraoperative coughs, laryngospasm)	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	up to 2 hours
Emergence times	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)]	up to 15 minutes

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Mark Coburn, Prof., University Hospital, Aachen

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 12, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Estimate): October 6, 2016
• Last Update Submitted That Met QC Criteria: October 5, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: sevoflurane; propofol; desflurane; laryngeal mask airway
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Desflurane; Sevoflurane
• Other Study ID Numbers: 14-073