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

Pr Isabelle CONSTANT1 site in 1 country66 target enrollmentFebruary 2006

ConditionsAnesthesia

InterventionsRemifentanil EEG Monitoring

DrugsPropofol : TCI Schnider Propofol : TCI Kataria Propofol : TIVA Remifentanil

Overview

Phase: Not Applicable
Intervention: Remifentanil
Conditions: Anesthesia
Sponsor: Pr Isabelle CONSTANT
Enrollment: 66
Locations: 1
Primary Endpoint: Percentage of time spent at adequate BIS values
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

March 2007

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pr Isabelle CONSTANT

Responsible Party

Sponsor Investigator

Principal Investigator

Pr Isabelle CONSTANT

Professor Isabelle Constant

Hôpital Armand Trousseau

Eligibility Criteria

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.