Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia

NCT ID: NCT02322502

Last Updated: 2016-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-02-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Anesthesia With Use of LMA (Laryngeal Mask Airway)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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desflurane

Suprane® Dose: 0.8 MAC / 4-5 vol. % Mode of administration: inhalation with laryngeal mask One application

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

intravenous injection to maintain anaesthesia

Interventions

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Desflurane

inhalation with laryngeal mask to maintain anaesthesia

Intervention Type DRUG

Sevoflurane

inhalation with laryngeal mask to maintain anaesthesia

Intervention Type DRUG

propofol

intravenous injection to maintain anaesthesia

Intervention Type DRUG

Other Intervention Names

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Suprane Sevorane Anesia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Martha-Maria Hospital Halle Dölau gGmbH, Department of Anesthesia

Halle, , Germany

Site Status

Kreiskliniken Reutlingen, Department of Anesthesia

Reutlingen, , Germany

Site Status

University Hospital Ulm, Department of Anesthesia

Ulm, , Germany

Site Status

Countries

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Germany

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.

Reference Type DERIVED
PMID: 29916859 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26210907 (View on PubMed)

Other Identifiers

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14-073

Identifier Type: -

Identifier Source: org_study_id

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