N/A
N=100
Cerebral Oxygenation in Total Hip Arthroplasty Patients
Cerebral Oxygen Desaturation · Post-operative Delirium
Bottom Line
View on ClinicalTrials.gov: NCT02325154 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Oxygen Desaturation Incidences — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cerebral Oximeter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxygen Desaturation Incidences |
4 | — |
| SECONDARY Duration of Oxygen Desaturation |
11 | — |
| SECONDARY Presence of Post-operative Delirium |
— | — |
| SECONDARY Patients With Cognitive Dysfunction |
3; 4; 3; 3 | — |
Summary
We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02325154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.