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Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia

Primary Purpose

General Anesthetic Drug Adverse Reaction

Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
desflurane - oxygen in air
desflurane - oxygen in nitric oxide
Sponsored by
University Hospital Hradec Kralove
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for General Anesthetic Drug Adverse Reaction focused on measuring Desflurane, end tidal concentration, age, anesthesia

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Hradec Kralove

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

desflurane - oxygen in air

desflurane - oxygen in nitric oxide

Arm Description

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

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%.

Outcomes

Primary Outcome Measures

end tidal concentration of desflurane according to age

Secondary Outcome Measures

Time to spontaneous ventilation
Time to extubation
Time to reaction to command
Wash in phase
sec
Wash out phase

Full Information

First Posted
November 15, 2015
Last Updated
October 15, 2016
Sponsor
University Hospital Hradec Kralove
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1. Study Identification

Unique Protocol Identification Number
NCT02617680
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Hradec Kralove

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthetic Drug Adverse Reaction
Keywords
Desflurane, end tidal concentration, age, anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
desflurane - oxygen in air
Arm Type
Experimental
Arm Description
The manufacturer recommended age-corrected end-tidal concentrations of desflurane in air should be set and achieved initially. Concentration of oxygen should be 50%.
Arm Title
desflurane - oxygen in nitric oxide
Arm Type
Experimental
Arm Description
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%.
Intervention Type
Drug
Intervention Name(s)
desflurane - oxygen in air
Other Intervention Name(s)
suprane
Intervention Description
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
Intervention Name(s)
desflurane - oxygen in nitric oxide
Other Intervention Name(s)
suprane
Intervention Description
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
Primary Outcome Measure Information:
Title
end tidal concentration of desflurane according to age
Time Frame
from the start of procedure up to 4 hours
Secondary Outcome Measure Information:
Title
Time to spontaneous ventilation
Time Frame
from end of anesthesia up to 1 hour
Title
Time to extubation
Time Frame
from the end of anesthesia up to 1 hour
Title
Time to reaction to command
Time Frame
from the end of anesthesia up to 1 hour
Title
Wash in phase
Description
sec
Time Frame
up to achievement of manufacturer age-corrected end-tidal concentrations of desflurane up to 10 minutes
Title
Wash out phase
Time Frame
from the end of procedure up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vlasta Dostalova, MD., Ph.D.
Organizational Affiliation
University Hospital Hradec Kralove, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic

12. IPD Sharing Statement

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Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia

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