Cerebral Oxygenation in Total Hip Arthroplasty Patients

NCT02325154 | Completed Results

• 1 other identifier: 2014-047
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Oxygen Desaturation; Post-operative Delirium

Outcome Measures

Primary Outcomes (1)

• Oxygen Desaturation Incidences

  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.

  Intra-operation (when the patient enters the operating room, up to 4 hours)

Secondary Outcomes (3)

• Duration of Oxygen Desaturation

  Intra-op ( during the time the patient is in the operating room, up to 4 hours)

• Presence of Post-operative Delirium

  Post-op Day 1, Post-op Day 2

• Patients With Cognitive Dysfunction

  Post-op Day 1, Post-op Day 2

Study Arms (1)

THA Patients

EXPERIMENTAL

Patients undergoing unilateral total hip arthroplasty

Device: Cerebral Oximeter

Interventions

Cerebral Oximeter DEVICE

Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.

Also known as: oximeter

THA Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-80 years old undergoing unilateral total hip arthroplasty
• Hypotensive epidural anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (7)

• 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.

  PMID: 7791257 BACKGROUND

• 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.

  PMID: 15765453 RESULT

• 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.

  PMID: 22754416 RESULT

• 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.

  PMID: 21866430 RESULT

• 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.

  PMID: 22962570 RESULT

• McDaniel M, Brudney C. Postoperative delirium: etiology and management. Curr Opin Crit Care. 2012 Aug;18(4):372-6. doi: 10.1097/MCC.0b013e3283557211.

  PMID: 22732435 RESULT

• 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.

  PMID: 20508134 RESULT

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Sean Garvin
• Organization: Hospital for Special Surgery, Anesthesiology

GarvinS@hss.edu

2126061036

Study Officials

• Sean Garvin, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 24, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 27, 2024
• Results First Posted: March 1, 2023

Record last verified: 2024-04

Locations

US (1)