Trial | NCT02637726  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    propofol remifentanil ...

  • Study Participants

    66
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 Started
Feb 28
2006
Primary Completion
Mar 31
2007
Study Completion
Mar 31
2007
Last Update
Dec 22
2015
Estimate

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

  • Other names: BISPECTRAL INDEX

Drug Remifentanil

Remifentanil at discretion of the anesthesiologist

TIVA0 Experimental

Propofol : TIVA guided by clinical signs. Remifentanil

TIVA BIS Experimental

propofol : TIVA guided by EEG Monitoring. Remifentanil

TCI KBIS Experimental

Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil.

TCI SBIS Experimental

Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil.

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.
No Results Posted