Clinical trial NCT02325154: Cerebral Oxygenation in Total Hip Arthroplasty Patients
Official title: Cerebral Near-Infrared Spectroscopy and Hypotensive Anesthesia in Patients Undergoing Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Oxygen Desaturation
Post-operative Delirium
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Oxygen Desaturation Incidences
timeFrame: Intra-operation (when the patient enters the operating room, up to 4 hours)
Secondary outcomes:
measure: Duration of Oxygen Desaturation
timeFrame: Intra-op ( during the time the patient is in the operating room, up to 4 hours)
measure: Presence of Post-operative Delirium
timeFrame: Post-op Day 1, Post-op Day 2
measure: Patients With Cognitive Dysfunction
timeFrame: Post-op Day 1, Post-op Day 2
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Sean Garvin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams-Russo P, Sharrock NE, Mattis S, Szatrowski TP, Charlson ME. Cognitive effects after epidural vs general anesthesia in older adults. A randomized trial. JAMA. 1995 Jul 5;274(1):44-50.
citation: Sharrock NE, Fischer G, Goss S, Flynn E, Go G, Sculco TP, Salvati EA. The early recovery of cognitive function after total-hip replacement under hypotensive epidural anesthesia. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):123-7. doi: 10.1016/j.rapm.2004.12.005.
citation: Rade MC, Yadeau JT, Ford C, Reid MC. Postoperative delirium in elderly patients after elective hip or knee arthroplasty performed under regional anesthesia. HSS J. 2011 Jul;7(2):151-6. doi: 10.1007/s11420-011-9195-2. Epub 2011 Feb 11.
citation: Yadeau JT, Liu SS, Bang H, Shaw PM, Wilfred SE, Shetty T, Gordon M. Cerebral oximetry desaturation during shoulder surgery performed in a sitting position under regional anesthesia. Can J Anaesth. 2011 Nov;58(11):986-92. doi: 10.1007/s12630-011-9574-7. Epub 2011 Aug 25.
citation: Papadopoulos G, Karanikolas M, Liarmakopoulou A, Papathanakos G, Korre M, Beris A. Cerebral oximetry and cognitive dysfunction in elderly patients undergoing surgery for hip fractures: a prospective observational study. Open Orthop J. 2012;6:400-5. doi: 10.2174/1874325001206010400. Epub 2012 Sep 3.
citation: McDaniel M, Brudney C. Postoperative delirium: etiology and management. Curr Opin Crit Care. 2012 Aug;18(4):372-6. doi: 10.1097/MCC.0b013e3283557211.
citation: Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Vaughn J, Nisman M. Cerebral oxygen desaturation events assessed by near-infrared spectroscopy during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesth Analg. 2010 Aug;111(2):496-505. doi: 10.1213/ANE.0b013e3181e33bd9. Epub 2010 May 27.