Remifentanil Propofol Infusion in Pediatric Spinal Surgery - Full Text View

Sponsors and Collaborators:	Children's Hospital of Philadelphia Children's Anesthesiology Associates
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00761072

Purpose

TIVA (total intravenous anesthesia) 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 Medvis display and compare the manual dosage schemes to the predicted effect site concentrations and pharmacodynamic effect.

Condition
Spinal Fusion

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Remifentanil hydrochloride Remifentanil Propofol

U.S. FDA Resources

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

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. ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 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 TIVA, the anesthetic propofol and the opioid remifentanil are often used together. Previous studies have demonstrated the synergy between these combinations of medications. 5-7From these data, drug interaction models have been developed to pair drug effect-site concentrations with event markers of interest to the clinical anesthesiologist.8 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.9 Likewise, the blood concentration levels present during emergence from anesthesia have been explored describing levels typically present for patients to return to consciousness.9 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

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
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:

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

Exclusion Criteria:

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761072

Contacts

Contact: Chad Gripe, MD	215-590-1864	gripec@email.chop.edu
Contact: Jeffrey M. Feldman, MD	267-426-7439	feldmanj@email.chop.edu

Locations

United States, Pennsylvania
The Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Cripe Chad, MD 215-590-1864 cripec@email.chop.edu
Contact: Jeffrey M. Feldman, MD 267-426-7439 feldmanj@email.chop.edu
Principal Investigator: Jeffrey M. Feldman, MD

Sponsors and Collaborators

Children's Hospital of Philadelphia

Children's Anesthesiology Associates

Investigators

Principal Investigator:

Jeffrey M. Feldman, MD

Children's Hospital of Philadelphia

More Information

No publications provided

Responsible Party:	The Children's Hospital of Philadelphia ( Jeffrey M. Feldman, MD )
Study ID Numbers:	2008-05-6048
Study First Received:	September 25, 2008
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00761072 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:

Propofol
Remifentanil
Total Intravenous Anesthesia

Study placed in the following topic categories:

Anesthetics, Intravenous
Remifentanil
Anesthetics, General
Hypnotics and Sedatives
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Analgesics
Propofol
Analgesics, Opioid

Additional relevant MeSH terms:

Anesthetics, Intravenous
Remifentanil
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Sensory System Agents

Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009