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Intravenous Versus Inhalational Anesthesia in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00615472
Recruitment Status : Terminated (Lack of funding)
First Posted : February 14, 2008
Results First Posted : July 13, 2015
Last Update Posted : July 13, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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hospital stays and a greater chance of not returning to independent living compared to age-matched controls (Berman MF, unpublished data).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 or disease Intervention/treatment
Parkinson's Disease Drug: Isoflurane Drug: Remifentanil Drug: Propofol

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Intravenous General Anesthesia Versus Inhalational General Anesthesia in Parkinson's Disease
Study Start Date : October 2003
Primary Completion Date : April 2010
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1
Inhaled Anesthesia - isoflurane
Drug: Isoflurane
Group 1 Inhaled anesthesia Patients will be 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 will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
Other Name: Forane
Experimental: Group 2
Intravenous Anesthesia - propofol, remifentanil
Drug: Remifentanil
Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min. These will be titrated as needed to maintain a standard blood pressure. Both infusions will be turned off at the end of the procedure. If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
Other Name: Ultiva
Drug: Propofol
Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min. These will be titrated as needed to maintain a standard blood pressure. Both infusions will be turned off at the end of the procedure. If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
Other Name: Diprivan


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Improved Postoperative Delirium and Cognitive and Motor Changes [ Time Frame: Four months ]
    A battery/Questionnaire of neuropsych examinations is given to the subjects to measure improvement based on change of scores and standard deviation. The battery consists of questions regarding delirium, cognitive and motor changes and yields a combination assessment of all 3 elements.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not fluent in English
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): 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
First Posted: February 14, 2008    Key Record Dates
Results First Posted: July 13, 2015
Last Update Posted: July 13, 2015
Last Verified: June 2015

Keywords provided by Eric J. Heyer, MD, PhD, 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
Propofol
Remifentanil
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation