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Interest of the Induction With Target-controlled Inhalation of Sevoflurane on Spikes Wave Occurrence (SIZE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00775879
First received: October 17, 2008
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

Sevoflurane is widely used for induction of anaesthesia. Several studies showed EEG abnormalities during mask induction with sevoflurane. The aim of our study was to test the induction target concentration of sevoflurane on the spikes wave occurrence.


Condition Intervention
General Anesthesia
 Drug: Induction with Sevoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Interest of the Induction With Target-controlled Inhalation of Sevoflurane on Spikes Wave Occurrence

Resource links provided by NLM:

Drug Information available for: Sevoflurane
U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Incidence of spike wave [ Time Frame: during anaesthesia induction with sevoflurane ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: March 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
2.5% target concentration
 Drug: Induction with Sevoflurane
Active Comparator: B
2.5% manually selected
 Drug: Induction with Sevoflurane

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • programmed gynecological surgery
  • ASA 1 or 2

Exclusion Criteria:

  • arterial hypertension
  • gastro-oesophageal reflux
  • pregnancy
  • diabetes
  • obesity
  • asthma
  • tobacco
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775879

Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Benjamin JULLIAC, Dr University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00775879     History of Changes
Other Study ID Numbers: CHUBX 2004/01
Study First Received: October 17, 2008
Last Updated: May 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Général anesthesia
Gynecology

Additional relevant MeSH terms:
Sevoflurane
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013