Cognitive Dysfunction in Hypertensive Patients Having Spine Surgery (HTN)
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Cognitive Dysfunction in Hypertensive Patients Having Spine Surgery|
- 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.
- 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.
|Study Start Date:||January 2009|
|Study Completion Date:||December 2014|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Patients with a history of hypertension will be in a group called "hypertension".
Patients without a history of hypertension or treatment for hypertension will be in the group called "normotension".
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01140854
|United States, New York|
|New York, New York, United States, 10032|
|Principal Investigator:||Eric J Heyer, MD, PhD||Columbia University|