- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02637726
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75012
- Departement d'anesthesie Hopital Armand Trousseau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TIVA0
Propofol : TIVA guided by clinical signs.
Remifentanil
|
Total intravenous anesthesia without use of a pharmokinetic model
Remifentanil at discretion of the anesthesiologist
|
Experimental: TIVA BIS
propofol : TIVA guided by EEG Monitoring.
Remifentanil
|
Total intravenous anesthesia without use of a pharmokinetic model
Remifentanil at discretion of the anesthesiologist
Maintaining a bispectral index between 45 and 55
Other Names:
|
Experimental: TCI KBIS
Propofol : TCI Kataria guided by EEG Monitoring.
Remifentanil.
|
Remifentanil at discretion of the anesthesiologist
Maintaining a bispectral index between 45 and 55
Other Names:
Target controlled infusion using Kataria model for propofol
|
Experimental: TCI SBIS
Propofol : TCI Schnider guided by EEG Monitoring.
Remifentanil.
|
Remifentanil at discretion of the anesthesiologist
Maintaining a bispectral index between 45 and 55
Other Names:
Target controlled infusion using schnider model for propofol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of time spent at adequate BIS values
Time Frame: from the beginning to the end of the anesthesia
|
from the beginning to the end of the anesthesia
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Isabelle Constant, PhD, Hôpital Armand Trousseau
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIVCM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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