Use of Closed-loop Anesthesia in Pediatric Patients (LoopPed)

Hopital Foch

Status and phase: Terminated; Phase 4

Conditions: Anesthesia

Treatments: Drug: Remifentanil; Drug: Propofol; Drug: remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT00778505

2008/21

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

1

Experimental group

Description:

closed-loop administration of propofol and remifentanil using bispectral index as the controller

Treatment:

Drug: remifentanil

Drug: Propofol

Drug: Propofol

2

Active Comparator group

Description:

manual administration of propofol and remifentanil according to bispectral index values

Treatment:

Drug: Propofol

Drug: Propofol

Drug: Remifentanil