Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia

General Anesthetic Drug Adverse Reaction Clinical Trial

Official title:

Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617680
• Other study ID #: 201404515P
• Status: Completed
• Phase: N/A
• First received: November 15, 2015
• Last updated: October 15, 2016
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• General Anesthetic Drug Adverse Reaction

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Czech Republic	University Hospital Hradec Kralove	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	end tidal concentration of desflurane according to age		from the start of procedure up to 4 hours	Yes
Secondary	Time to spontaneous ventilation		from end of anesthesia up to 1 hour	Yes
Secondary	Time to extubation		from the end of anesthesia up to 1 hour	Yes
Secondary	Time to reaction to command		from the end of anesthesia up to 1 hour	Yes
Secondary	Wash in phase	sec	up to achievement of manufacturer age-corrected end-tidal concentrations of desflurane up to 10 minutes	Yes
Secondary	Wash out phase		from the end of procedure up to 1 hour	Yes