NCT02637726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

December 16, 2015

Last Update Submit

December 21, 2015

Conditions

Anesthesia

Keywords

Total intravenous anesthesiaTarget Controlled InfusionPropofolBispectral indexChildren

Outcome Measures

Primary Outcomes (1)

  • Percentage of time spent at adequate BIS values

    from the beginning to the end of the anesthesia

Study Arms (4)

TIVA0

EXPERIMENTAL

Propofol : TIVA guided by clinical signs. Remifentanil

Drug: Propofol : TIVADrug: Remifentanil

TIVA BIS

EXPERIMENTAL

propofol : TIVA guided by EEG Monitoring. Remifentanil

Drug: Propofol : TIVADevice: EEG MonitoringDrug: Remifentanil

TCI KBIS

EXPERIMENTAL

Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil.

Drug: Propofol : TCI KatariaDevice: EEG MonitoringDrug: Remifentanil

TCI SBIS

EXPERIMENTAL

Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil.

Drug: Propofol : TCI SchniderDevice: EEG MonitoringDrug: Remifentanil

Interventions

Propofol : TCI SchniderDRUG

Target controlled infusion using schnider model for propofol

TCI SBIS
Propofol : TCI KatariaDRUG

Target controlled infusion using Kataria model for propofol

TCI KBIS
Propofol : TIVADRUG

Total intravenous anesthesia without use of a pharmokinetic model

TIVA BISTIVA0
EEG MonitoringDEVICE

Maintaining a bispectral index between 45 and 55

Also known as: BISPECTRAL INDEX
TCI KBISTCI SBISTIVA BIS
RemifentanilDRUG

Remifentanil at discretion of the anesthesiologist

TCI KBISTCI SBISTIVA BISTIVA0

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • weighting more than 15 kg;
  • American Society of Anesthesiologists physical status I or II
  • scheduled for middle ear surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement d'anesthesie Hopital Armand Trousseau

Paris, 75012, France

Location

MeSH Terms

Interventions

Consciousness MonitorsRemifentanil

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and SuppliesPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Isabelle Constant, PhD

    Hôpital Armand Trousseau

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Isabelle Constant

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 22, 2015

Study Start

February 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

December 22, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)