Use of Closed-loop Anesthesia in Pediatric Patients

Anesthesia Clinical Trial

— LoopPed  

Official title:

Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison in Pediatric Patients Between Manual Perfusion and Automated Perfusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00778505
• Other study ID #: 2008/21
• Status: Terminated
• Phase: Phase 4
• First received: October 22, 2008
• Last updated: September 22, 2016
• Start date: October 2008
• Est. completion date: December 2012

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• class ASA I, II or III

• general anesthesia scheduled to last more than one hour

• intraoperative hemorrhage planned to be less than 15% of the blood volume

Exclusion Criteria:

• Combined general and regional anesthesia,

• Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure,

• History of a neurological or a psychiatric disorder, or central brain lesion,

• Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,

• Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component,

• Hypersensibility to remifentanil or to a derivate of fentanyl,

• Scheduled postoperative ventilation or sedation.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Propofol
closed-loop administration using bispectral index as the controller
• remifentanil
closed-loop administration using bispectral index as the controller
• Propofol
manual administration according bispectral index values
• Remifentanil
manual administration according bispectral index values

Locations

Country	Name	City	State
France	Hôpital Necker Enfants	Paris
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time during which the bispectral index is between 40 and 60		anesthesia	No
Secondary	propofol and remifentanil doses		anesthesia	No