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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637726
• Other study ID #: AIVCM
• Status: Completed
• Phase: N/A
• First received: December 16, 2015
• Last updated: December 21, 2015
• Start date: February 2006
• Est. completion date: March 2007

Study information

• Verified date: December 2015
• Source: Hôpital Armand Trousseau
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Propofol : TCI Schnider
Target controlled infusion using schnider model for propofol
• Propofol : TCI Kataria
Target controlled infusion using Kataria model for propofol
• Propofol : TIVA
Total intravenous anesthesia without use of a pharmokinetic model

Device:
• EEG Monitoring
Maintaining a bispectral index between 45 and 55

Drug:
• Remifentanil
Remifentanil at discretion of the anesthesiologist

Locations

Country	Name	City	State
France	Departement d'anesthesie Hopital Armand Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pr Isabelle CONSTANT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time spent at adequate BIS values		from the beginning to the end of the anesthesia	No