NCT02322502

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

December 12, 2014

Last Update Submit

October 5, 2016

Conditions

Anesthesia With Use of LMA (Laryngeal Mask Airway)

Keywords

laryngeal mask airwaydesfluranesevofluranepropofol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Airway reactions (Incidence of intraoperative coughs, laryngospasm)

    up to 2 hours

  • Emergence times

    up to 15 minutes

Study Arms (3)

desflurane

EXPERIMENTAL

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

Drug: Desflurane

sevoflurane

ACTIVE COMPARATOR

Sevoflurane: Dose: 0.8 MAC / 1.2-1.4 vol.% Mode of administration: inhalation with laryngeal mask One application

Drug: Sevoflurane

propofol

ACTIVE COMPARATOR

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

Interventions

DesfluraneDRUG

inhalation with laryngeal mask to maintain anaesthesia

Also known as: Suprane
desflurane
SevofluraneDRUG

inhalation with laryngeal mask to maintain anaesthesia

Also known as: Sevorane
sevoflurane
propofolDRUG

intravenous injection to maintain anaesthesia

Also known as: Anesia
propofol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

RWTH Aachen University; Department of Anesthesia

Aachen, D-52074, Germany

Location

Martha-Maria Hospital Halle Dölau gGmbH, Department of Anesthesia

Halle, 06120, Germany

Location

Kreiskliniken Reutlingen, Department of Anesthesia

Reutlingen, 73764, Germany

Location

University Hospital Ulm, Department of Anesthesia

Ulm, 89075, Germany

Location

Related Publications (2)

  • 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.

    PMID: 29916859DERIVED

  • 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.

    PMID: 26210907DERIVED

MeSH Terms

Interventions

DesfluraneSevofluranePropofol

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Mark Coburn, Prof.

    University Hospital, Aachen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2014

First Posted

December 23, 2014

Study Start

February 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

October 6, 2016

Record last verified: 2016-10

Locations

DE(4)