LoopPed: Use of Closed-loop Anesthesia in Pediatric Patients

• Sponsor: Hopital Foch (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00778505
• Collaborator: (none)
• Enrollment: 45
• Locations: 2
• Arms: 2
• Duration (Months): 50
• Patients Per Site: 22.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Propofol; Drug: remifentanil; Drug: Propofol; Drug: Remifentanil	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 closed-loop administration of propofol and remifentanil using bispectral index as the controller	Drug: Propofol; closed-loop administration using bispectral index as the controller; Drug: remifentanil; closed-loop administration using bispectral index as the controller
Active Comparator: 2 manual administration of propofol and remifentanil according to bispectral index values	Drug: Propofol; manual administration according bispectral index values; Drug: Remifentanil; manual administration according bispectral index values

Outcome Measures

Primary Outcome Measures

1. Percentage of time during which the bispectral index is between 40 and 60 [anesthesia]

Secondary Outcome Measures

1. propofol and remifentanil doses [anesthesia]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Necker Enfants	Paris		France	75015
2	Hôpital Foch	Suresnes		France	92150

Sponsors and Collaborators

• Hopital Foch

Investigators

• Study Chair: Marc Fischler, MD, Hôpital Foch, Suresnes, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT00778505
• Other Study ID Numbers: 2008/21
• First Posted: Oct 23, 2008
• Last Update Posted: Sep 23, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Hopital Foch: Anesthesia
• Additional relevant MeSH terms: Remifentanil; Propofol

Study Results

No Results Posted as of Sep 23, 2016