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NCT Number: NCT02617680

Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia

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.

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Key information

Conditions

General Anesthetic Drug Adverse Reaction

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

desflurane - oxygen in air

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

Other names: suprane

desflurane - oxygen in nitric oxide

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

Other names: suprane

Primary outcomes

  1. end tidal concentration of desflurane according to age

    Time frame: from the start of procedure up to 4 hours

Secondary outcomes

  1. Time to spontaneous ventilation

    Time frame: from end of anesthesia up to 1 hour

  2. Time to extubation

    Time frame: from the end of anesthesia up to 1 hour

  3. Time to reaction to command

    Time frame: from the end of anesthesia up to 1 hour

  4. Wash in phase

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

    sec

  5. Wash out phase

    Time frame: from the end of procedure up to 1 hour

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2015
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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