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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: EEG Monitoring; Drug: Remifentanil

• Registration Number: NCT02637726
• Lead Sponsor: Pr Isabelle CONSTANT

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2015-12
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-21
• Last Update Submitted: 2015-12-21
• Study First Posted: 2015-12-22
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIVA BIS	EEG Monitoring	propofol : TIVA guided by EEG Monitoring. Remifentanil
TCI SBIS	EEG Monitoring	Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil.
TCI KBIS	EEG Monitoring	Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil.
TIVA BIS	Remifentanil	propofol : TIVA guided by EEG Monitoring. Remifentanil
TIVA0	Remifentanil	Propofol : TIVA guided by clinical signs. Remifentanil
TCI KBIS	Remifentanil	Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil.
TCI SBIS	Remifentanil	Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil.

Primary Outcome Measures

Name	Time	Method
Percentage of time spent at adequate BIS values	from the beginning to the end of the anesthesia

Trial Locations

Locations (1)

Departement d'anesthesie Hopital Armand Trousseau; 🇫🇷 Paris, France