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Cognitive Dysfunction in Hypertensive Patients Having Spine Surgery (HTN)

This study is currently recruiting participants.
Verified November 2012 by Columbia University
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Eric J. Heyer, MD, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT01140854
First received: June 2, 2010
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

While hypotension during general anesthesia has routinely been considered to be a tolerable abnormality with little clinical consequence, the proposed study takes the innovative approach of defining hypotensive events within the construct of a patient's own hypertensive status, fractional mean arterial blood pressure (fMAP). Because the investigators primary variable is within the control of anesthesia personnel, the study portends a potentially simple and easy to implement treatment. The introduction of neuropsychometric measures as the relevant evaluator of post-operative cognitive dysfunction is innovative, and may be more relevant to the average elderly patient than simple mortality.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cognitive Dysfunction in Hypertensive Patients Having Spine Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Neuropsychometric changes at 1 day [ Time Frame: Baseline to 1 Day ] [ Designated as safety issue: Yes ]
    The investigators will determine whether there are neuropsychometric changes associated with simple spine surgery as a function of arterial blood pressure measurements relative to the patient's baseline values at 1 day.


Secondary Outcome Measures:
  • Neuropsychometric Changes at 1 Month [ Time Frame: Baseline to 1 Month ] [ Designated as safety issue: Yes ]
    The investigators will determine whether there are neuropsychometric changes associated with simple spine surgery as a function of arterial blood pressure measurements relative to the patient's baseline values at 1 month.


Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hypertension
Patients with a history of hypertension will be in a group called "hypertension".
Normotension
Patients without a history of hypertension or treatment for hypertension will be in the group called "normotension".

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients >60 years old will be recruited who are scheduled for elective simple spine surgery (microdiskectomy or 1-2 level laminectomies without fusion) and lasting <5 hours without blood transfusion.

Criteria

Inclusion Criteria:

  • elective spine surgery > 60 years old < 5 hours of surgery microdiskectomy 1-2 levels of spinal laminectomies

Exclusion Criteria:

  • Transfusions > 5 hours of surgery >2 levels of laminectomies Spinal instrumentation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140854

Contacts
Contact: Joanna L Mergeche, BA 2123058949 jm3596@columbia.edu
Contact: Eric J Heyer, MD, PhD 212-305-9072 ejh3@columbia.edu

Locations
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Principal Investigator: Eric J Heyer, MD, PhD            
Sponsors and Collaborators
Columbia University
Weill Medical College of Cornell University
Investigators
Principal Investigator: Eric J Heyer, MD, PhD Columbia University
  More Information

Publications:

Responsible Party: Eric J. Heyer, MD, PhD, Professor of Anesthesiology, Clinical Operations, Columbia University
ClinicalTrials.gov Identifier: NCT01140854     History of Changes
Other Study ID Numbers: AAAD3838
Study First Received: June 2, 2010
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
hypertension
hypotension
cognitive
neurocognitive
 cognitive dysfunction
postoperative cognitive dysfunction (POCD)
neuropsychometric

Additional relevant MeSH terms:
Hypertension
Cognition Disorders
Vascular Diseases
 Cardiovascular Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013