Cerebral Oxygenation in Total Hip Arthroplasty Patients

Not Applicable

Completed

Conditions: Cerebral Oxygen Desaturation
Post-operative Delirium

Interventions: Device: Cerebral Oximeter

Registration Number: NCT02325154

Lead Sponsor: Hospital for Special Surgery, New York

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
THA Patients	Cerebral Oximeter	Patients undergoing unilateral total hip arthroplasty

Primary Outcome Measures

Name	Time	Method
Oxygen Desaturation Incidences	Intra-operation (when the patient enters the operating room, up to 4 hours)	The number of participant's experiencing an intra-operative cerebral oxygen desaturation event. Measured in the number of patients, beginning with the time the patients' enters the operating room and up to 4 hours.

Secondary Outcome Measures

Name	Time	Method
Duration of Oxygen Desaturation	Intra-op ( during the time the patient is in the operating room, up to 4 hours)	Duration of cerebral oxygen desaturation
Presence of Post-operative Delirium	Post-op Day 1, Post-op Day 2	The number of patients who have post-operative delirium, as determined by counting the patients who suffer from this condition. Although recorded at various time points, the total number of participants experiencing post-operative delirium was summed and reported.
Patients With Cognitive Dysfunction	Post-op Day 1, Post-op Day 2	The number of patients considered to experience cognitive dysfunction as identified by low scores on the mini-Cog. The Mini-Cog checks for the brain function (or the cognitive impairment) of the participant. The Mini-Cog does this by examining a patient's ability in two areas. This is done via a three-word recall test and the Clock Drawing Test. 1. Three-Word Recall 2. The Clock Drawing Test (CDT) There are five total points a person can score on the Mini-Cog: * Give one point for each word that was correctly remembered. (0-3 points) * Give two points for a correctly drawn clock, meaning the numbers are in roughly the correct locations and two hands are pointed to the 11 and the 2. The length of the hands does not matter. (0 or 2 points) If a patient scores less than three points, they are counted as experiencing cognitive dysfunction. Although collected across different time points, the total number of patients scoring less than 3 points were summed and reported.