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

Primary Purpose

General Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Induction with Sevoflurane
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for General Anesthesia focused on measuring Général anesthesia, Gynecology

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • programmed gynecological surgery
  • ASA 1 or 2

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    A

    B

    Arm Description

    2.5% target concentration

    2.5% manually selected

    Outcomes

    Primary Outcome Measures

    Incidence of spike wave

    Secondary Outcome Measures

    Full Information

    First Posted
    October 17, 2008
    Last Updated
    May 17, 2013
    Sponsor
    University Hospital, Bordeaux
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00775879
    Brief Title
    Interest of the Induction With Target-controlled Inhalation of Sevoflurane on Spikes Wave Occurrence
    Acronym
    SIZE
    Official Title
    Interest of the Induction With Target-controlled Inhalation of Sevoflurane on Spikes Wave Occurrence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2006 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    July 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Bordeaux

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    General Anesthesia
    Keywords
    Général anesthesia, Gynecology

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    2.5% target concentration
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Description
    2.5% manually selected
    Intervention Type
    Drug
    Intervention Name(s)
    Induction with Sevoflurane
    Primary Outcome Measure Information:
    Title
    Incidence of spike wave
    Time Frame
    during anaesthesia induction with sevoflurane

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: programmed gynecological surgery ASA 1 or 2 Exclusion Criteria: arterial hypertension gastro-oesophageal reflux pregnancy diabetes obesity asthma tobacco
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Benjamin JULLIAC, Dr
    Organizational Affiliation
    University Hospital, Bordeaux
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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