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

NCT ID: NCT02637726

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia

Keywords

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Total intravenous anesthesia Target Controlled Infusion Propofol Bispectral index Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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TIVA0

Propofol : TIVA guided by clinical signs. Remifentanil

Group Type EXPERIMENTAL

Propofol : TIVA

Intervention Type DRUG

Total intravenous anesthesia without use of a pharmokinetic model

Remifentanil

Intervention Type DRUG

Remifentanil at discretion of the anesthesiologist

TIVA BIS

propofol : TIVA guided by EEG Monitoring. Remifentanil

Group Type EXPERIMENTAL

Propofol : TIVA

Intervention Type DRUG

Total intravenous anesthesia without use of a pharmokinetic model

EEG Monitoring

Intervention Type DEVICE

Maintaining a bispectral index between 45 and 55

Remifentanil

Intervention Type DRUG

Remifentanil at discretion of the anesthesiologist

TCI KBIS

Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil.

Group Type EXPERIMENTAL

Propofol : TCI Kataria

Intervention Type DRUG

Target controlled infusion using Kataria model for propofol

EEG Monitoring

Intervention Type DEVICE

Maintaining a bispectral index between 45 and 55

Remifentanil

Intervention Type DRUG

Remifentanil at discretion of the anesthesiologist

TCI SBIS

Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil.

Group Type EXPERIMENTAL

Propofol : TCI Schnider

Intervention Type DRUG

Target controlled infusion using schnider model for propofol

EEG Monitoring

Intervention Type DEVICE

Maintaining a bispectral index between 45 and 55

Remifentanil

Intervention Type DRUG

Remifentanil at discretion of the anesthesiologist

Interventions

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Propofol : TCI Schnider

Target controlled infusion using schnider model for propofol

Intervention Type DRUG

Propofol : TCI Kataria

Target controlled infusion using Kataria model for propofol

Intervention Type DRUG

Propofol : TIVA

Total intravenous anesthesia without use of a pharmokinetic model

Intervention Type DRUG

EEG Monitoring

Maintaining a bispectral index between 45 and 55

Intervention Type DEVICE

Remifentanil

Remifentanil at discretion of the anesthesiologist

Intervention Type DRUG

Other Intervention Names

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BISPECTRAL INDEX

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pr Isabelle CONSTANT

OTHER

Sponsor Role lead

Responsible Party

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Pr Isabelle CONSTANT

Professor Isabelle Constant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Isabelle Constant, PhD

Role: STUDY_DIRECTOR

Hôpital Armand Trousseau

Locations

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Departement d'anesthesie Hopital Armand Trousseau

Paris, , France

Site Status

Countries

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France

Other Identifiers

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AIVCM

Identifier Type: -

Identifier Source: org_study_id