Intravenous Versus Inhalational Anesthesia in Parkinson's Disease

June 19, 2015 updated by: Eric J. Heyer, MD, PhD, Columbia University

Intravenous General Anesthesia Versus Inhalational General Anesthesia in Parkinson's Disease

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hospital stays and a greater chance of not returning to independent living compared to age-matched controls (Berman MF, unpublished data).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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

We will compare the groups in terms of postoperative delirium, and cognitive and motor function changes. Patients randomized to an inhaled anesthetic will receive a standard anesthetic mix: an inhaled anesthetic with intravenous agents for rapid induction of anesthesia, narcotics for postoperative pain relief, and muscle relaxation. Patients randomized to IV anesthesia will receive a continuous infusion of propofol and remifentanil (ultrashort acting narcotic) instead of the inhalation anesthetics during the maintenance phase of the anesthetic. Other components of the anesthetic will be the same as in the "inhaled anesthetic" group.

We hypothesize that:

  1. Patients with Parkinson's disease will have less postoperative delirium and less prolonged cognitive and motor changes after total intravenous anesthesia than following inhaled anesthesia.
  2. Apolipoprotein E4 (Apo E4) allele will be associated with postoperative cognitive dysfunction in Parkinsonian patients

To test our hypotheses we will:

  1. Randomize patients with Parkinson's disease having surgery for implantation of current generator for subthalamic stimulator to receive either a total intravenous anesthetic or an inhaled anesthetic.
  2. Compare these two groups of patients for incidence of postoperative delirium and the degree of postoperative cognitive and motor dysfunction.
  3. Test for an association between the (Apo E4) allele and postoperative cognitive change. A buccal sampling or cheek cell sampling method will be employed to obtain DNA for genotyping of the Apo E allele.

During the procedure, maintenance of anesthesia will differ for the two groups:

Group 1 Inhaled anesthesia: Patients will be maintained on oxygen and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice).

Group 2 Intravenous anesthesia: Patients will be ventilated with 50% oxygen in air. Patients will 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. These will be titrated as needed to maintain a standard blood pressure. Both infusions will be turned off at the end of the procedure.

Testing of Motor and Cognitive Status. Patients who participate in the study will be given a mental status examination, tests of Parkinsonian motor symptoms, and tests of cognitive function in the preoperative period before implantation of the subthalamic electrodes and implantation of current generators. Subsets of these tests will be performed several times postoperatively (1 month and 4 months)

Implantation of Electrode (Stage I sedation anesthesia) Full testing will be done in the preoperative period. Patients are generally kept in the hospital overnight and discharged the following day. Mental status will be rechecked by the MMSE in the recovery room postoperatively .

Patients will be contacted by telephone to have their mental status assessed by telephone using using two well known examinations (Telephone Interview for Cognitive Status (TICS) and Centers for Disease Control and Prevention Health-Related Quality-of-Life 14Item Measure (CDC HRQOL14)) and a series of questions investigating how well patients are able to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs). These tests will be given at two time points, once before the surgery and then one month after surgery. We will look for changes in quality of life that may correlate with neuropsychometric test performance.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia Unviversity, Deparment of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not fluent in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Eric J Heyer, M.D., Ph.D., Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 9, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

July 13, 2015

Last Update Submitted That Met QC Criteria

June 19, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAA4885

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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