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

Pr Isabelle CONSTANT

Status: Completed

Conditions: Anesthesia

Treatments: Device: EEG Monitoring; Drug: Remifentanil; Drug: Propofol : TCI Schnider; Drug: Propofol : TCI Kataria; Drug: Propofol : TIVA

Study type: Interventional

Funder types: Other

Identifiers

NCT02637726

AIVCM

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 4 patient groups

TIVA0

Experimental group

Description:

Propofol : TIVA guided by clinical signs. Remifentanil

Treatment:

Drug: Remifentanil

Drug: Propofol : TIVA

TIVA BIS

Experimental group

Description:

propofol : TIVA guided by EEG Monitoring. Remifentanil

Treatment:

Drug: Remifentanil

Device: EEG Monitoring

Drug: Propofol : TIVA

TCI KBIS

Experimental group

Description:

Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil.

Treatment:

Drug: Propofol : TCI Kataria

Drug: Remifentanil

Device: EEG Monitoring

TCI SBIS

Experimental group

Description:

Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil.

Treatment:

Drug: Propofol : TCI Schnider

Drug: Remifentanil

Device: EEG Monitoring