Use of Closed-Loop Anesthesia in Pediatric Patients - Full Text View

Sponsored by:	Hopital Foch
Information provided by:	Hopital Foch
ClinicalTrials.gov Identifier:	NCT00778505

Purpose

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

Condition	Intervention	Phase
Anesthesia	Drug: Propofol Drug: remifentanil Drug: Remifentanil	Phase IV

MedlinePlus related topics: Anesthesia

Drug Information available for: Propofol Remifentanil Remifentanil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison in Pediatric Patients Between Manual Perfusion and Automated Perfusion

Further study details as provided by Hopital Foch:

Primary Outcome Measures:

Percentage of time during which the bispectral index is between 40 and 60 [ Time Frame: anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

propofol and remifentanil doses [ Time Frame: anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental closed-loop administration of propofol and remifentanil using bispectral index as the controller	Drug: Propofol closed-loop administration using bispectral index as the controller Drug: remifentanil closed-loop administration using bispectral index as the controller
2: Active Comparator manual administration of propofol and remifentanil according to bispectral index values	Drug: Propofol manual administration according bispectral index values Drug: Remifentanil manual administration according bispectral index values

Eligibility

Ages Eligible for Study:	6 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778505

Contacts

Contact: Marc Fischler, MD

0033146252442

m.fischler@hopital-foch.org

Locations

France
Hôpital Necker Enfants	Recruiting
Paris, France, 75015
Contact: Gilles Orliaguet, MD 0033144494458 gilles.orliaguet@nck.aphp.fr)
Hôpital Foch	Active, not recruiting
Suresnes, France, 92150

Sponsors and Collaborators

Hopital Foch

Investigators

Study Chair:

Marc Fischler, MD

Hôpital Foch, Suresnes, France

More Information

Responsible Party:	Hopital Foch ( Pr. Marc Fischler )
Study ID Numbers:	2008/21
Study First Received:	October 22, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00778505
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hopital Foch:

Anesthesia

Study placed in the following topic categories:

Remifentanil
Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Anesthetics, General
Sensory System Agents

Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 14, 2009