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

NCT02637726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2015-12-22

No results posted yet for this study

Summary

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.

Conditions

  • Anesthesia

Interventions

DRUG

Propofol : TCI Schnider

Target controlled infusion using schnider model for propofol

DRUG

Propofol : TCI Kataria

Target controlled infusion using Kataria model for propofol

DRUG

Propofol : TIVA

Total intravenous anesthesia without use of a pharmokinetic model

DEVICE

EEG Monitoring

Maintaining a bispectral index between 45 and 55

DRUG

Remifentanil

Remifentanil at discretion of the anesthesiologist

Sponsors & Collaborators

  • Pr Isabelle CONSTANT

    lead OTHER

Principal Investigators

  • Isabelle Constant, PhD · Hôpital Armand Trousseau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02637726 on ClinicalTrials.gov