Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia

October 15, 2016 updated by: Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic, 50005
        • University Hospital Hradec Kralove

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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%.
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
Other Names:
  • suprane
EXPERIMENTAL: 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%.
Drug: 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
Other Names:
  • suprane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
end tidal concentration of desflurane according to age
Time Frame: from the start of procedure up to 4 hours
from the start of procedure up to 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to spontaneous ventilation
Time Frame: from end of anesthesia up to 1 hour
from end of anesthesia up to 1 hour
Time to extubation
Time Frame: from the end of anesthesia up to 1 hour
from the end of anesthesia up to 1 hour
Time to reaction to command
Time Frame: from the end of anesthesia up to 1 hour
from the end of anesthesia up to 1 hour
Wash in phase
Time Frame: up to achievement of manufacturer age-corrected end-tidal concentrations of desflurane up to 10 minutes
sec
up to achievement of manufacturer age-corrected end-tidal concentrations of desflurane up to 10 minutes
Wash out phase
Time Frame: from the end of procedure up to 1 hour
from the end of procedure up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Investigators

  • Principal Investigator: Vlasta Dostalova, MD., Ph.D., University Hospital Hradec Kralove, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

November 15, 2015

First Submitted That Met QC Criteria

November 26, 2015

First Posted (ESTIMATE)

December 1, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 15, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201404515P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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