Cognitive Dysfunction in Hypertensive Patients Having Spine Surgery (HTN)

This study has been completed.
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: June 2, 2015
Last verified: June 2015
  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 Intervention
Hypertension
Procedure: Lumbar spine surgery
Other: Neurologic/neuropsychometric examinations

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.


Enrollment: 179
Study Start Date: January 2009
Study Completion Date: December 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hypertension (case)
Elderly patients 60 years old or older undergoing simple lumbar spine surgery under general anesthesia will receive neurologic/neuropsychometric examinations.
Procedure: Lumbar spine surgery
(non-experimental) we do not intend to change the criteria of selection for simple lumbar spine surgery, anesthesia, or the postoperative management of the patients studied.
Other: Neurologic/neuropsychometric examinations
To measure postoperative cognitive dysfunction.
Normotension (control)
Middle-aged patients (40-60 years) undergoing simple lumbar spine surgery under general anesthesia as controls to compare their performance to those patients >60 years - will also receive neurologic/neuropsychometric examinations.
Procedure: Lumbar spine surgery
(non-experimental) we do not intend to change the criteria of selection for simple lumbar spine surgery, anesthesia, or the postoperative management of the patients studied.
Other: Neurologic/neuropsychometric examinations
To measure postoperative cognitive dysfunction.

  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

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
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: June 2, 2015
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:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 01, 2015