Expired Study
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New York, New York 10021


Purpose:

We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.


Study summary:

The relationship between cerebral oxygenation and blood pressure in patients undergoing hypotensive epidural anesthesia has not been completely elucidated. Previous publications have demonstrated a low incidence of post-op cognitive dysfunction in patients undergoing hypotensive epidural anesthesia for total hip replacement (1-3) and that cerebral blood flow velocity is preserved as measured by transcranial Doppler (4). An earlier investigation by Dr. Yadeau demonstrated infrequent cerebral oxygen desaturation in spontaneously breathing patients undergoing shoulder arthroscopy, even in the presence of hypotension (4), but did not investigate outcomes in the cognitive domain or have a control group of patients undergoing surgery with general anesthesia. There has only been one study looking at cerebral oxygenation and hip surgery, which was performed in elderly patients with fractures. It demonstrated that patients with low pre-op regional cerebral oxygen saturation (rSO2) had higher incidence of delirium (5) but many of those patients had surgery under general anesthesia. Given the costs associated with post-op delirium, cognitive dysfunction and stroke (6) and based on the fact that previous publications from this institution have demonstrated both a low incidence of cognitive dysfunction and preservation of cerebral blood flow velocity using this anesthetic technique, we hypothesized that cerebral oxygen desaturation will not occur in this population.


Criteria:

Inclusion Criteria: - Patients 18-80 years old undergoing unilateral total hip arthroplasty - Hypotensive epidural anesthesia Exclusion Criteria: - Contraindication to controlled hypotension and/or neuraxial anesthesia. - Severe pulmonary hypertension or pre-op systolic blood pressure reading >150 mm Hg - Moderate to severe valvular stenosis. - History of stroke, dementia, or post-op delirium - Prior OSA diagnosis - History of benzodiazepine use (regular use for longer than 3 months) - Chronic renal or hepatic disease (renal failure, history of liver failure, cirrhosis) - History of alcoholism or heavy alcohol intake (defined as averaging more than 3 drinks per night; recovery is OK) - Parkinson's disease - Severe chronic pulmonary disease - Total anterior hip approach being used - Hip resurfacing procedure - Non-English Speaking* - Questionnaires being used to assess mental status are only validated in English.


NCT ID:

NCT02325154


Primary Contact:

Principal Investigator
Sean Garvin, MD
Hospital for Special Surgery, New York


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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