Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia
NCT ID: NCT02322502
Last Updated: 2016-10-06
Study Results
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Basic Information
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COMPLETED
PHASE3
352 participants
INTERVENTIONAL
2015-02-28
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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desflurane
Suprane® Dose: 0.8 MAC / 4-5 vol. % Mode of administration: inhalation with laryngeal mask One application
Desflurane
inhalation with laryngeal mask to maintain anaesthesia
sevoflurane
Sevoflurane:
Dose: 0.8 MAC / 1.2-1.4 vol.% Mode of administration: inhalation with laryngeal mask One application
Sevoflurane
inhalation with laryngeal mask to maintain anaesthesia
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
propofol
intravenous injection to maintain anaesthesia
Interventions
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Desflurane
inhalation with laryngeal mask to maintain anaesthesia
Sevoflurane
inhalation with laryngeal mask to maintain anaesthesia
propofol
intravenous injection to maintain anaesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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RWTH Aachen University
OTHER
Responsible Party
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Principal Investigators
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Mark Coburn, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Aachen
Locations
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RWTH Aachen University; Department of Anesthesia
Aachen, , Germany
Martha-Maria Hospital Halle Dölau gGmbH, Department of Anesthesia
Halle, , Germany
Kreiskliniken Reutlingen, Department of Anesthesia
Reutlingen, , Germany
University Hospital Ulm, Department of Anesthesia
Ulm, , Germany
Countries
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References
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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.
Other Identifiers
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14-073
Identifier Type: -
Identifier Source: org_study_id
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