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Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia

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ClinicalTrials.gov Identifier: NCT02322502
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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

Condition or disease Intervention/treatment Phase
Anesthesia With Use of LMA (Laryngeal Mask Airway) Drug: Desflurane Drug: Sevoflurane Drug: propofol Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia: a Randomized Multicenter Controlled Trial (ACC Baxter)
Study Start Date : February 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Anesia




Primary Outcome Measures :
  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 Outcome Measures :
  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)]



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322502


Locations
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Germany
RWTH Aachen University; Department of Anesthesia
Aachen, Germany, D-52074
Martha-Maria Hospital Halle Dölau gGmbH, Department of Anesthesia
Halle, Germany, 06120
Kreiskliniken Reutlingen, Department of Anesthesia
Reutlingen, Germany, 73764
University Hospital Ulm, Department of Anesthesia
Ulm, Germany, 89075
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Mark Coburn, Prof. University Hospital, Aachen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02322502    
Other Study ID Numbers: 14-073
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Keywords provided by RWTH Aachen University:
laryngeal mask airway
desflurane
sevoflurane
propofol
Additional relevant MeSH terms:
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Propofol
Sevoflurane
Desflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation