Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia

NCT ID: NCT02617680

Last Updated: 2016-10-18

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

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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All patients with American Society of Anesthesiologists (ASA) physical status I-III scheduled for elective neurosurgical procedure under general anaesthesia are studied. In each individual, the manufacturer recommended age-corrected end-tidal concentrations of desflurane is set and achieved initially. Individual effective end-tidal concentration (EEtC) of desflurane is then defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50. Effective analgesia is maintained according to surgical plethysmographic index (SPI) and dose of muscle relaxants according to neuromuscular transmission monitoring (TOF). Comorbidity, regular intake of alcohol and medication, smoking, sex, weight, height, and age are recorded. Postoperative questionnaire is used to reveal the intraoperative awareness.

Conditions

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General Anesthetic Drug Adverse Reaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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desflurane - oxygen in air

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

Group Type EXPERIMENTAL

desflurane - oxygen in air

Intervention Type DRUG

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

desflurane - oxygen in nitric oxide

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%.

Group Type EXPERIMENTAL

desflurane - oxygen in nitric oxide

Intervention Type DRUG

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

Interventions

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desflurane - oxygen in air

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

Intervention Type DRUG

desflurane - oxygen in nitric oxide

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

Intervention Type DRUG

Other Intervention Names

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suprane suprane

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Glasgow coma scale GCS below 14
* other rhythm than sinus
* pacemaker stimulation
* planned postoperative ventilation
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Hradec Kralove

OTHER

Sponsor Role lead

Responsible Party

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Dostalova Vlasta, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vlasta Dostalova, MD., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Hradec Kralove, Czech Republic

Locations

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University Hospital Hradec Kralove

Hradec Králové, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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201404515P

Identifier Type: -

Identifier Source: org_study_id

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