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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00778505
Other study ID # 2008/21
Secondary ID
Status Terminated
Phase Phase 4
First received October 22, 2008
Last updated September 22, 2016
Start date October 2008
Est. completion date December 2012

Study information

Verified date September 2016
Source Hopital Foch
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

To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia


Recruitment information / eligibility

Status Terminated
Enrollment 45
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 16 Years
Eligibility Inclusion Criteria:

- class ASA I, II or III

- general anesthesia scheduled to last more than one hour

- intraoperative hemorrhage planned to be less than 15% of the blood volume

Exclusion Criteria:

- Combined general and regional anesthesia,

- Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure,

- History of a neurological or a psychiatric disorder, or central brain lesion,

- Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,

- Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component,

- Hypersensibility to remifentanil or to a derivate of fentanyl,

- Scheduled postoperative ventilation or sedation.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Propofol
closed-loop administration using bispectral index as the controller
remifentanil
closed-loop administration using bispectral index as the controller
Propofol
manual administration according bispectral index values
Remifentanil
manual administration according bispectral index values

Locations

Country Name City State
France Hôpital Necker Enfants Paris
France Hôpital Foch Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of time during which the bispectral index is between 40 and 60 anesthesia No
Secondary propofol and remifentanil doses anesthesia No
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