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Sponsors and Collaborators: |
Children's Hospital of Philadelphia Children's Anesthesiology Associates |
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Information provided by: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT00761072 |
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 |
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Spinal Fusion |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | An Evaluation of RemifentanilPropofol Infusion in Pediatric Spinal Surgery |
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 |
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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
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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.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Pediatric patients having spinal surgery procedures completed at CHOP from April 2007 through March 2008
Inclusion Criteria:
Exclusion Criteria:
Contact: Chad Gripe, MD | 215-590-1864 | gripec@email.chop.edu |
Contact: Jeffrey M. Feldman, MD | 267-426-7439 | feldmanj@email.chop.edu |
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 |
Principal Investigator: | Jeffrey M. Feldman, MD | Children's Hospital of Philadelphia |
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 |
Propofol Remifentanil Total Intravenous Anesthesia |
Anesthetics, Intravenous Remifentanil Anesthetics, General Hypnotics and Sedatives Central Nervous System Depressants |
Anesthetics Peripheral Nervous System Agents Analgesics Propofol Analgesics, Opioid |
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 |