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

September 22, 2016 updated by: Hopital Foch

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Necker Enfants
      • Suresnes, France, 92150
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Propofol
manual administration according bispectral index values
Active Comparator: 2
manual administration of propofol and remifentanil according to bispectral index values
Drug: Propofol
closed-loop administration using bispectral index as the controller
Drug: Propofol
manual administration according bispectral index values
Drug: Remifentanil
manual administration according bispectral index values

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time during which the bispectral index is between 40 and 60
Time Frame: anesthesia
anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
propofol and remifentanil doses
Time Frame: anesthesia
anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Study Chair: Marc Fischler, MD, Hôpital Foch, Suresnes, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 22, 2008

First Submitted That Met QC Criteria

October 22, 2008

First Posted (Estimate)

October 23, 2008

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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