Skip to main content
OpenTrials
Completed

NCT Number: NCT02637726

Bispectral Index Under Propofol Anesthesia in Children : a 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol : TCI Schnider

Drug

Target controlled infusion using schnider model for propofol

Propofol : TCI Kataria

Drug

Target controlled infusion using Kataria model for propofol

Propofol : TIVA

Drug

Total intravenous anesthesia without use of a pharmokinetic model

EEG monitoring

Device

Maintaining a bispectral index between 45 and 55

Other names: BISPECTRAL INDEX

Remifentanil

Drug

Remifentanil at discretion of the anesthesiologist

Primary outcomes

  1. Percentage of time spent at adequate BIS values

    Time frame: from the beginning to the end of the anesthesia

Sponsors and collaborators

Lead sponsor

Pr Isabelle CONSTANT

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 22, 2015
Registry last updated
Dec 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.