Cognitive Dysfunction in Hypertensive Patients Having Spine Surgery (HTN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 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: July 29, 2013
Last verified: July 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140854

Contacts
Contact: Kaitlin A Mallon, BA 2123058949 km2954@cumc.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: July 29, 2013
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 October 19, 2014