Use of Closed-loop Anesthesia in Pediatric Patients

Phase 4

Terminated

• Conditions: Anesthesia
• Interventions: Drug: Propofol; Drug: Remifentanil

• Registration Number: NCT00778505
• Lead Sponsor: Hopital Foch

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-23
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Remifentanil	closed-loop administration of propofol and remifentanil using bispectral index as the controller
1	Propofol	closed-loop administration of propofol and remifentanil using bispectral index as the controller
2	Propofol	manual administration of propofol and remifentanil according to bispectral index values
2	Remifentanil	manual administration of propofol and remifentanil according to bispectral index values

Primary Outcome Measures

Name	Time	Method
Percentage of time during which the bispectral index is between 40 and 60	anesthesia

Secondary Outcome Measures

Name	Time	Method
propofol and remifentanil doses	anesthesia

Trial Locations

Locations (2)

Hôpital Foch; 🇫🇷 Suresnes, France

Hôpital Necker Enfants; 🇫🇷 Paris, France