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Use of Closed-loop Anesthesia in Pediatric Patients (LoopPed)

This study is currently recruiting participants.
Verified September 2012 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00778505
First received: October 22, 2008
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  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 4

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

Resource links provided by NLM:

U.S. FDA Resources

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: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Active Comparator: 2
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

No publications provided

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00778505     History of Changes
Other Study ID Numbers: 2008/21
Study First Received: October 22, 2008
Last Updated: September 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Foch:
Anesthesia

Additional relevant MeSH terms:
Anesthetics
Propofol
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013