Affect of Different Types of Anesthetic Techniques on Cognition in Patients With Parkinson's Disease

This study has been withdrawn prior to enrollment.
(Withdrawn: study halted prematurely, prior to enrollment of first participant)
Sponsor:
Information provided by (Responsible Party):
Eric J. Heyer, MD, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT00615472
First received: January 9, 2008
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

Parkinson's disease is a common progressive degenerative disease affecting 3% of all patients over the age of 65. Given their age and frailty, these patients frequently require surgical procedures with general anesthesia. However, after surgery, patients with Parkinson's disease have longer hospital stays and a greater chance of not returning to independent living compared to age-matched controls (Berman MF, unpublished data). In part, this is due to a higher rate of post-operative delirium, which had an incidence of 60% in this population in one study. There is anecdotal evidence from neurologists specializing in movement disorder suggesting that there is also significant deterioration in parkinsonian motor symptoms and cognition lasting for months or years following surgery and anesthesia. The basis for this deterioration is unknown. We hypothesize that these problems are caused by particular medications used during inhaled anesthesia for surgical procedures.


Condition Intervention
Parkinson's Disease
Drug: Isoflurane
Drug: Propofol and Remifentanil

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Intravenous General Anesthesia Versus Inhalational General Anesthesia in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Postoperative delirium and cognitive and motor changes. [ Time Frame: Four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Apolipoprotein E4 (Apo E4) allele in association with postoperative cognitive change in Parkinsonian patients. [ Time Frame: Four months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2003
Study Completion Date: April 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Isoflurane
    Group 1 Inhaled anesthesia Patients maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation provided by additional boluses or an infusion of mivacurium (410 ug/kg/min).
    Drug: Propofol and Remifentanil
    Group 2 Intravenous anesthesia Patients ventilated with 50% oxygen in air. Patients receive continuous propofol infusion 0.05 mg/kgmin to 0.15 mg/kgmin titrated as needed; and remifentanil (ultrashort acting narcotic) 0.1 ug/kgmin to 0.5 ug/kgmin. Titration as needed to maintain a standard blood pressure. Both infusions turned off at the end of the procedure. If needed, muscle relaxation provided by additional boluses or an infusion of mivacurium (410 ug/kg/min).
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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's Disease with bilateral deep brain stimulation surgery indicated as treatment

Exclusion Criteria:

  • non fluent English
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00615472

Locations
United States, New York
Columbia Unviversity, Deparment of Anesthesiology
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Eric J Heyer, M.D., Ph.D. Columbia University
  More Information

Publications:
Brandt R, Spencer M, Folstein M: The Telephone Interview for Cognitive Status. Neuropsychiatry, Neuropsychology, and Behavioral Neurology 1:111-117, 1988.
Culley DJ, Yukhananov RY, Baxter MB, Crosby G: Longerterm cognitive performance after general anesthesia in aged rats. J Neurosurg Anesthesiol 12:395 (abstract 325), 2000.
Spreen O, Strauss E: A compendium of Neuropsychological tests. New York, Oxford University Press, 1998, ed second.

Responsible Party: Eric J. Heyer, MD, PhD, Professor of Clinical Anesthesiology, Columbia University
ClinicalTrials.gov Identifier: NCT00615472     History of Changes
Other Study ID Numbers: AAAA4885
Study First Received: January 9, 2008
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Parkinson's Disease
Deep brain stimulation (DBS)
Subthalamic Nucleus
Total Intravenous Anesthesia
Inhalational Anesthesia

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Anesthetics
Isoflurane
Propofol
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Anesthetics, Intravenous
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014