Clinical trial NCT02617680: Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia
Official title: Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthetic Drug Adverse Reaction
Keywords: Desflurane
end tidal concentration
age
anesthesia
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: end tidal concentration of desflurane according to age
timeFrame: from the start of procedure up to 4 hours
Secondary outcomes:
measure: Time to spontaneous ventilation
timeFrame: from end of anesthesia up to 1 hour
measure: Time to extubation
timeFrame: from the end of anesthesia up to 1 hour
measure: Time to reaction to command
timeFrame: from the end of anesthesia up to 1 hour
measure: Wash in phase
timeFrame: up to achievement of manufacturer age-corrected end-tidal concentrations of desflurane up to 10 minutes
measure: Wash out phase
timeFrame: from the end of procedure up to 1 hour
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove, Czech Republic
name: Vlasta Dostalova, MD., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: