NCT02617680

Brief Summary

There is accumulating evidence that inappropriate depth of anaesthesia is associated with increased risk of postoperative complications including risk of death. The aim of this study was to identify factors determining the effective end-tidal concentration (EEtC) of desflurane, duration of wash in and wash out phase, and to estimate the risk of perioperative awareness in patients undergoing elective neurosurgical procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

10 months

First QC Date

November 15, 2015

Last Update Submit

October 15, 2016

Conditions

General Anesthetic Drug Adverse Reaction

Keywords

Desfluraneend tidal concentrationageanesthesia

Outcome Measures

Primary Outcomes (1)

  • end tidal concentration of desflurane according to age

    from the start of procedure up to 4 hours

Secondary Outcomes (5)

  • Time to spontaneous ventilation

    from end of anesthesia up to 1 hour

  • Time to extubation

    from the end of anesthesia up to 1 hour

  • Time to reaction to command

    from the end of anesthesia up to 1 hour

  • Wash in phase

    up to achievement of manufacturer age-corrected end-tidal concentrations of desflurane up to 10 minutes

  • Wash out phase

    from the end of procedure up to 1 hour

Study Arms (2)

desflurane - oxygen in air

EXPERIMENTAL

The manufacturer recommended age-corrected end-tidal concentrations of desflurane in air should be set and achieved initially. Concentration of oxygen should be 50%.

Drug: desflurane - oxygen in air

desflurane - oxygen in nitric oxide

EXPERIMENTAL

The manufacturer recommended age-corrected end-tidal concentrations of desflurane with nitric oxide - oxygen should be set and achieved initially.Concentration of oxygen should be 50%.

Drug: desflurane - oxygen in nitric oxide

Interventions

desflurane - oxygen in airDRUG

The manufacturer recommended age-corrected end-tidal concentrations of desflurane in air should be set and achieved initially. Individual EEtC of desflurane will be defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50

Also known as: suprane
desflurane - oxygen in air
desflurane - oxygen in nitric oxideDRUG

The manufacturer recommended age-corrected end-tidal concentrations of desflurane with nitric oxide - oxygen should be set and achieved initially. Individual EEtC of desflurane will be defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50

Also known as: suprane
desflurane - oxygen in nitric oxide

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • elective neurosurgical procedure under general anaesthesia
  • Age between 18 and 78
  • elective procedures with estimated duration 1 - 3 hours

You may not qualify if:

  • Glasgow coma scale GCS below 14
  • other rhythm than sinus
  • pacemaker stimulation
  • planned postoperative ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

MeSH Terms

Interventions

AirDesfluraneNitric Oxide

Intervention Hierarchy (Ancestors)

AtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public HealthEthyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsReactive Nitrogen SpeciesFree RadicalsInorganic ChemicalsNitrogen OxidesNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • Vlasta Dostalova, MD., Ph.D.

    University Hospital Hradec Kralove, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2015

First Posted

December 1, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

CZ(1)