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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00775879
Other study ID # CHUBX 2004/01
Secondary ID
Status Completed
Phase N/A
First received October 17, 2008
Last updated May 17, 2013
Start date March 2006
Est. completion date July 2008

Study information

Verified date May 2013
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- programmed gynecological surgery

- ASA 1 or 2

Exclusion Criteria:

- arterial hypertension

- gastro-oesophageal reflux

- pregnancy

- diabetes

- obesity

- asthma

- tobacco

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Induction with Sevoflurane


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of spike wave during anaesthesia induction with sevoflurane Yes
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