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Remifentanil Propofol Infusion in Pediatric Spinal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00761072
First Posted: September 26, 2008
Last Update Posted: March 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Anesthesiology Associates, Ltd.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
  Purpose
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.

Condition
Spinal Fusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Evaluation of RemifentanilPropofol Infusion in Pediatric Spinal Surgery

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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 [ Time Frame: Between 4/1/2007 until 3/31/2008. ]

Secondary Outcome Measures:
  • The secondary objectives are to determine the variability in propofol-remifentanil TIVA dosing in a population of surgical patients [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4/1/2007 - 3/31/2009 ]

Enrollment: 12
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

During Total intravenous anesthesia (TIVA), the anesthetic propofol and the opioid remifentanil are often used together. Previous studies have demonstrated the synergy between these combinations of medications. From these data, drug interaction models have been developed to pair drug effect-site concentrations with event markers of interest to the clinical anesthesiologist. For example, the amount of remifentanil and propofol typically required during the induction of anesthesia to cause loss of responsiveness to verbal or moderate stimuli has been studied. Likewise, the blood concentration levels present during emergence from anesthesia have been explored describing levels typically present for patients to return to consciousness.

The purpose of this study is to retrospectively analyze the infusion doses of both remifentanil and propofol for pediatric patients undergoing spinal fusion surgery at CHOP. These data will be applied to the pharmacokinetic models to determine the predicted effect site concentration, and the relationship of that concentration to the 50% and 95% doses as predicted by the model.

  Eligibility

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric patients having spinal surgery procedures completed at CHOP from April 2007 through March 2008
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Chronic opioid or benzodiazepine medication use prior to surgery
  2. Use of other anesthetic infusions (i.e. Ketamine/Fentanyl) during TIVA
  3. Use of Neuraxial opioids
  4. Use of other Induction medications (i.e. Sodium Thiopental)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761072


Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Investigators
Principal Investigator: Jeffrey M. Feldman, MD Children's Hospital of Philadelphia
  More Information

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00761072     History of Changes
Other Study ID Numbers: 2008-05-6048
First Submitted: September 25, 2008
First Posted: September 26, 2008
Last Update Posted: March 7, 2013
Last Verified: March 2013

Keywords provided by Children's Hospital of Philadelphia:
Propofol
Remifentanil
Total Intravenous Anesthesia

Additional relevant MeSH terms:
Propofol
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents