Status:
TERMINATED
Use of Closed-loop Anesthesia in Pediatric Patients
Lead Sponsor:
Hopital Foch
Conditions:
Anesthesia
Eligibility:
All Genders
6-16 years
Phase:
PHASE4
Brief Summary
To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00778505
Start Date
October 1 2008
End Date
December 1 2012
Last Update
September 23 2016
Active Locations (2)
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1
Hôpital Necker Enfants
Paris, France, 75015
2
Hôpital Foch
Suresnes, France, 92150