NCT00775879

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
Last Updated

May 20, 2013

Status Verified

May 1, 2013

Enrollment Period

2.3 years

First QC Date

October 17, 2008

Last Update Submit

May 17, 2013

Conditions

General Anesthesia

Keywords

Général anesthesiaGynecology

Outcome Measures

Primary Outcomes (1)

  • Incidence of spike wave

    during anaesthesia induction with sevoflurane

Study Arms (2)

A

EXPERIMENTAL

2.5% target concentration

Drug: Induction with Sevoflurane

B

ACTIVE COMPARATOR

2.5% manually selected

Drug: Induction with Sevoflurane

Interventions

Induction with SevofluraneDRUG
AB

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • programmed gynecological surgery
  • ASA 1 or 2

You may not qualify if:

  • arterial hypertension
  • gastro-oesophageal reflux
  • pregnancy
  • diabetes
  • obesity
  • asthma
  • tobacco

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Neoadjuvant TherapySevoflurane

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Benjamin JULLIAC, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 20, 2008

Study Start

March 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

May 20, 2013

Record last verified: 2013-05