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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02637726

Enrollment

Registered

2015-12-22

Start date

2006-02-28

Completion date

2007-03-31

Last updated

2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Total intravenous anesthesia, Target Controlled Infusion, Propofol, Bispectral index, Children

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.

Interventions

DRUGPropofol : TCI Schnider

Target controlled infusion using schnider model for propofol

DRUGPropofol : TCI Kataria

Target controlled infusion using Kataria model for propofol

DRUGPropofol : TIVA

Total intravenous anesthesia without use of a pharmokinetic model

DEVICEEEG Monitoring

Maintaining a bispectral index between 45 and 55

DRUGRemifentanil

Remifentanil at discretion of the anesthesiologist

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

4 Years to 16 Years

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.

Design outcomes

Primary

Measure	Time frame
Percentage of time spent at adequate BIS values	from the beginning to the end of the anesthesia

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026