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HypertensionHTNNCT01140854

Cognitive Dysfunction in Hypertensive Patients Having Spine Surgery

An observational study of Hypertension, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 60 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
Lumbar spine surgery and Neurologic/neuropsychometric examinations
Type of treatment
Surgery or procedure
How many people
179 participants
Where
1 siteUnited States
Study dates
Jan 2009to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • transfusions
  • > 5 hours of surgery
  • > 2 levels of laminectomies
  • spinal instrumentation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Columbia University

    New York, New York, 10032

Other trials in United States

About this study

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.

Read the detailed description

After major non-cardiac and non-cerebral surgery, postoperative cognitive dysfunction (POCD) occurs in a significant percentage of patients. The consequences of POCD are profound. Elderly patients having POCD at 1 week have an increased risk of disability or voluntary early retirement, and patients having POCD at 3 months have increased mortality.

The effect of low arterial blood pressure, called hypotension, during surgery on the incidence of POCD is not obvious. This effect has been obscured in a number of previous studies because, it was assumed that hypotension had to persist for minutes to hours to be deleterious, when, in fact, the duration is uncertain. In addition, patient outcomes were not analyzed as a function of a history of hypertension. In this research application, the investigators focus specifically on patients with a history of hypertension because their physiology is different than patients with normal arterial blood pressure. These hypertensive patients may be unable to compensate for low arterial blood pressure by a process called cerebral autoregulation. As a result, patients with a history of hypertension may be at greater risk for decreased cerebral perfusion and cerebral ischemia secondary to decreased systemic arterial blood pressure even during surgery for procedures not thought to put the brain at risk of ischemia.

In a prior retrospective study, the investigators analyzed hemodynamic data from fifty elderly (average age >60 years) patients having simple lumbar spine surgery, which is not thought to be associated with cerebral ischemia. These patients were all examined with a battery of neuropsychometric tests before and after surgery. Patients with a history of hypertension had cognitive changes that are dependent on the lowest fractional mean arterial blood pressure (fMAP), where fMAP is mean arterial blood pressure (MAP) divided by baseline MAP. Such changes were not found in patients without a history of hypertension. This relationship did not depend on the steady state fMAP or the highest fMAP reached in either group.

To confirm and extend these results the investigators therefore propose and hypothesize that: In patients with a history of hypertension, compared to patients without this history, low fMAPs during induction predict cognitive performance after surgery.

To evaluate these hypotheses the investigators will determine the incidence of post-operative cognitive dysfunction (POCD) as a function of the fMAP in hypertensive and normotensive patients undergoing elective simple lumbar spine surgery.

If the proposed study demonstrates that acute intra-operative episodes of hypotension are deleterious to cognitive performance in patients with hypertension, and that there are demonstrable consequences in terms of QOL measures, the possibility of a direct and low cost intervention will be available that will lead directly to an efficacy trial using non-invasive measures of cerebral blood flow algorithms to prevent POCD.

The investigators plan to conduct a multicenter study in which 200 elderly patients (>60 years) are tested with a validated battery of 6 neuropsychometric tests before simple elective lumbar spine surgery (microdiscectomy or 1-2 level laminectomies without fusions lasting <5 hours and not requiring blood transfusions) and two times after surgery, at 24 hours and at 1 month. Two questionnaires for QOL will be performed before surgery and at 1 month. Patients will be questioned whether they have a history of hypertension, and, if they do, then its duration and treatment.

Our analysis will be based on comparing the fMAP to the neuropsychometric performance before and after surgery. To see if neuropsychometric changes occur as a component of a routine anesthetic, anesthesiologists will not be given a specific protocol for intraoperative management.

The primary outcome measure will be changes in test performance between baseline and the post-operative period at 1 day and 1 month. This primary measure will be a rating of overall change in performance compared to three values of fMAPs: lowest, steady state and highest fMAP attained. Our analysis will also include uni- and multi-variate analyses which will include and QOL.

Conditions
Hypertension
Being tested
Lumbar spine surgery, Neurologic/neuropsychometric examinations
Keywords
hypertension, hypotension, cognitive, neurocognitive, cognitive dysfunction, postoperative cognitive dysfunction (POCD), neuropsychometric
Medical subject headings
Hypertension, Hypotension, Cognitive Dysfunction, Postoperative Cognitive Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lumbar spine surgeryProcedure or 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.

  • Neurologic/neuropsychometric examinationsOther

    To measure postoperative cognitive dysfunction.

Study groups in NCT01140854
Study groupRoleWhat they receive
Hypertension (case)Elderly patients 60 years old or older undergoing simple lumbar spine surgery under general anesthesia will receive neurologic/neuropsychometric examinations.
Receives: Procedure: Lumbar spine surgery; Other: Neurologic/neuropsychometric examinations
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.
Receives: Procedure: Lumbar spine surgery; Other: Neurologic/neuropsychometric examinations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuropsychometric changes at 1 day

    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.

    Measured: Baseline to 1 Day

Secondary outcomes (1)
  1. Neuropsychometric changes at 1 Month

    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.

    Measured: Baseline to 1 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionJan 2013
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01140854
Sponsor's protocol ID
AAAD3838
Acronym
HTN
Status last verified
Jun 2015
First submitted
2 Jun 2010
Last updated
4 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Yocum GT, Gaudet JG, Teverbaugh LA, Quest DO, McCormick PC, Connolly ES Jr, Heyer EJ. Neurocognitive performance in hypertensive patients after spine surgery. Anesthesiology. 2009 Feb;110(2):254-61. doi: 10.1097/ALN.0b013e3181942c7a.

    PubMed 19194152

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuropsychometric changes at 1 day (time frame: Baseline to 1 Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01140854, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.

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HTN Clinical Trial NCT01140854 | AzTrials