Remifentanil Propofol Infusion in Pediatric Spinal Surgery

NCT00761072 | Completed

• 1 other identifier: 2008-05-6048
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Total intravenous anesthesia(TIVA) is a commonly used anesthetic technique. Although TIVA can be accomplished with a variety of drug combinations, infusions of Propofol and Remifentanil are often used with dosage adjusted manually by the anesthesia provider.The pharmacokinetics of these drugs are well understood, and that knowledge has led to the development of computer controlled infusion pumps that can administer the drugs based upon pharmacokinetic models. Computer controlled infusion schemes automatically adjust the drug administration based upon pharmacokinetic models which typically dictate a tapering infusion scheme. When one considers the dosage of a computer controlled infusion it is obvious that manually imitating a similar scheme may be difficult.This study will evaluate manually controlled infusion schemes using the models built into the Applied Medical Visualizations (Medvis) display and compare the manual dosage schemes to the predicted effect site concentrations and pharmacodynamic effect.

Conditions

Spinal Fusion

Keywords

Propofol; Remifentanil; Total Intravenous Anesthesia

Outcome Measures

Primary Outcomes (1)

• The primary purpose of the study is to investigate the consistency in predicted effect site concentrations that result from manual administration of propofol and remifentanil for TIVA

  Between 4/1/2007 until 3/31/2008.

Secondary Outcomes (3)

• The secondary objectives are to determine the variability in propofol-remifentanil TIVA dosing in a population of surgical patients

  4/1/2007 to 3/39/2008

• The secondary objectives are to determine the variability in propofol-remifentanil TIVA dosing in a population of surgical patients

  4/1/2007 - 3/31/2008

• To gain insight into the potential benefit of using a real time display of predicted serum levels and pharmacodynamic response to guide manual drug infusion for TIVA

  4/1/2007 - 3/31/2009

Study Arms (1)

1

The source of data will be from spinal surgery procedures performed at CHOP from 4/1/07 to 3/31/08 using a TIVA anesthetic technique of propofol/remifentanil infusions

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric patients having spinal surgery procedures completed at CHOP from April 2007 through March 2008

You may qualify if:

• Male and Female patients age 0 to 18 years old
• Spinal surgery at CHOP between 4/1/07 and 3/31/08
• Complete CompuRecord Anesthesia documentation
• Use of Propofol and Remifentanil infusions as primary anesthetic technique

You may not qualify if:

• Chronic opioid or benzodiazepine medication use prior to surgery
• Use of other anesthetic infusions (i.e. Ketamine/Fentanyl) during TIVA
• Use of Neuraxial opioids
• Use of other Induction medications (i.e. Sodium Thiopental)

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Children's Anesthesiology Associates, Ltd.: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Jeffrey M. Feldman, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 26, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

US (1)