Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia

Not Applicable

Completed

• Conditions: General Anesthetic Drug Adverse Reaction
• Interventions: Drug: desflurane - oxygen in air; Drug: desflurane - oxygen in nitric oxide

• Registration Number: NCT02617680
• Lead Sponsor: University Hospital Hradec Kralove

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-11-15
• Study First Submitted QC: 2015-11-26
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Posted: 2015-12-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-15
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
desflurane - oxygen in air	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%.
desflurane - oxygen in nitric oxide	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%.

Primary Outcome Measures

Name	Time	Method
end tidal concentration of desflurane according to age	from the start of procedure up to 4 hours

Secondary Outcome Measures

Name	Time	Method
Time to extubation	from the end of anesthesia up to 1 hour
Time to spontaneous ventilation	from 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	sec
Wash out phase	from the end of procedure up to 1 hour

Trial Locations

Locations (1)

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czech Republic