Bispectral Index Under Propofol Anesthesia in Children : a Study Between TIVA and TCI

December 21, 2015 updated by: Pr Isabelle CONSTANT

Bispectral Index Under Propofol Anesthesia in Children : a Comparative Randomised Study Between TIVA and TCI

In children, only a few studies have compared different modes of propofol infusion during a total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values) between four modes of propofol infusion: titration of the infusion rate on clinical signs (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI SBIS).

Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate BIS values (45-55), the bias and imprecision will be calculated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

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, 75012
        • Departement d'anesthesie Hopital Armand Trousseau

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

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • weighting more than 15 kg;
  • American Society of Anesthesiologists physical status I or II
  • scheduled for middle ear surgery

Exclusion Criteria:

  • cardiovascular, neurological, hepatic or renal impairment, if their body mass index was above 95th percentile or if they received any drug interfering with the central nervous system.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIVA0
Propofol : TIVA guided by clinical signs. Remifentanil
Drug: Propofol : TIVA
Total intravenous anesthesia without use of a pharmokinetic model
Drug: Remifentanil
Remifentanil at discretion of the anesthesiologist
Experimental: TIVA BIS
propofol : TIVA guided by EEG Monitoring. Remifentanil
Drug: Propofol : TIVA
Total intravenous anesthesia without use of a pharmokinetic model
Drug: Remifentanil
Remifentanil at discretion of the anesthesiologist
Device: EEG Monitoring
Maintaining a bispectral index between 45 and 55
Other Names:
  • BISPECTRAL INDEX
Experimental: TCI KBIS
Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil.
Drug: Remifentanil
Remifentanil at discretion of the anesthesiologist
Device: EEG Monitoring
Maintaining a bispectral index between 45 and 55
Other Names:
  • BISPECTRAL INDEX
Drug: Propofol : TCI Kataria
Target controlled infusion using Kataria model for propofol
Experimental: TCI SBIS
Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil.
Drug: Remifentanil
Remifentanil at discretion of the anesthesiologist
Device: EEG Monitoring
Maintaining a bispectral index between 45 and 55
Other Names:
  • BISPECTRAL INDEX
Drug: Propofol : TCI Schnider
Target controlled infusion using schnider model for propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time spent at adequate BIS values
Time Frame: from the beginning to the end of the anesthesia
from the beginning to the end of the anesthesia

Collaborators and Investigators

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

Sponsor

Pr Isabelle CONSTANT

Investigators

  • Study Director: Isabelle Constant, PhD, Hôpital Armand Trousseau

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

February 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 22, 2015

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIVCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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