NCT01140854

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

4 years

First QC Date

June 2, 2010

Last Update Submit

June 2, 2015

Conditions

Hypertension

Keywords

hypertensionhypotensioncognitiveneurocognitivecognitive dysfunctionpostoperative cognitive dysfunction (POCD)neuropsychometric

Outcome Measures

Primary Outcomes (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.

    Baseline to 1 Day

Secondary Outcomes (1)

  • Neuropsychometric changes at 1 Month

    Baseline to 1 Month

Study Arms (2)

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 surgeryOther: 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.

Procedure: Lumbar spine surgeryOther: Neurologic/neuropsychometric examinations

Interventions

Lumbar spine surgeryPROCEDURE

(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.

Hypertension (case)Normotension (control)
Neurologic/neuropsychometric examinationsOTHER

To measure postoperative cognitive dysfunction.

Hypertension (case)Normotension (control)

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 19194152RESULT

MeSH Terms

Conditions

HypertensionHypotensionCognitive DysfunctionPostoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eric J Heyer, MD, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology, Clinical Operations

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 10, 2010

Study Start

January 1, 2009

Primary Completion

January 1, 2013

Study Completion

December 1, 2014

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

US(1)