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

Sponsor

Pr Isabelle CONSTANT (Other)

Overall Status

Completed

CT.gov ID

NCT02637726

Collaborator

(none)

Enrollment

Location

Arms

12.9

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Propofol : TCI Schnider Drug: Propofol : TCI Kataria Drug: Propofol : TIVA Device: EEG Monitoring Drug: Remifentanil	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TIVA0 Propofol : TIVA guided by clinical signs. Remifentanil	Drug: Propofol : TIVA Total intravenous anesthesia without use of a pharmokinetic model Drug: Remifentanil Remifentanil at discretion of the anesthesiologist
Experimental: TIVA BIS propofol : TIVA guided by EEG Monitoring. Remifentanil	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
Experimental: TCI KBIS Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil.	Drug: Propofol : TCI Kataria Target controlled infusion using Kataria model for propofol Device: EEG Monitoring Maintaining a bispectral index between 45 and 55 Other Names: BISPECTRAL INDEX Drug: Remifentanil Remifentanil at discretion of the anesthesiologist
Experimental: TCI SBIS Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil.	Drug: Propofol : TCI Schnider Target controlled infusion using schnider model for propofol Device: EEG Monitoring Maintaining a bispectral index between 45 and 55 Other Names: BISPECTRAL INDEX Drug: Remifentanil Remifentanil at discretion of the anesthesiologist

Outcome Measures

Primary Outcome Measures

Percentage of time spent at adequate BIS values [from the beginning to the end of the anesthesia]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 16 Years

Sexes Eligible for Study:

All

Accepts 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.