Interest of the Induction With Target-Controlled Inhalation of Sevoflurane on Spikes Wave Occurrence - Full Text View

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

This study has been completed.

Sponsored by:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00775879

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

MedlinePlus related topics: Anesthesia

Drug Information available for: Sevoflurane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study
Official Title:	Interest of the Induction With Target-Controlled Inhalation of Sevoflurane on Spikes Wave Occurrence

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
A: Experimental 2.5% target concentration	Drug: Induction with Sevoflurane
B: Active Comparator 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

Responsible Party:	University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers:	CHUBX 2004/01
Study First Received:	October 17, 2008
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00775879
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

Général anesthesia
Gynecology

Study placed in the following topic categories:

Sevoflurane

Additional relevant MeSH terms:

Anesthetics, Inhalation
Anesthetics, General
Therapeutic Uses
Physiological Effects of Drugs
Hematologic Agents

Central Nervous System Depressants
Anesthetics
Platelet Aggregation Inhibitors
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009