NCT00778505

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

4.2 years

First QC Date

October 22, 2008

Last Update Submit

September 22, 2016

Conditions

Anesthesia

Keywords

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Percentage of time during which the bispectral index is between 40 and 60

    anesthesia

Secondary Outcomes (1)

  • propofol and remifentanil doses

    anesthesia

Study Arms (2)

1

EXPERIMENTAL

closed-loop administration of propofol and remifentanil using bispectral index as the controller

Drug: PropofolDrug: remifentanil

2

ACTIVE COMPARATOR

manual administration of propofol and remifentanil according to bispectral index values

Drug: PropofolDrug: Remifentanil

Interventions

PropofolDRUG

closed-loop administration using bispectral index as the controller

1
RemifentanilDRUG

closed-loop administration using bispectral index as the controller

1

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Necker Enfants

Paris, 75015, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

MeSH Terms

Interventions

PropofolRemifentanil

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Marc Fischler, MD

    Hôpital Foch, Suresnes, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

FR(2)