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

Hopital Foch2 sites in 1 country45 target enrollmentOctober 2008

ConditionsAnesthesia

InterventionsPropofol Remifentanil

DrugsPropofol remifentanil Remifentanil

Overview

Phase: Phase 4
Intervention: Propofol
Conditions: Anesthesia
Sponsor: Hopital Foch
Enrollment: 45
Locations: 2
Primary Endpoint: Percentage of time during which the bispectral index is between 40 and 60
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

December 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hopital Foch

Responsible Party

Sponsor

Eligibility 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.