A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia

NCT02190903 | Completed Results DMC

• 1 other identifier: 818017
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot project will address the gaps in knowledge regarding the effect of anesthetic technique on the risk of delirium through an adequately-powered trial employing standardized regimens for treatment and outcome assessment to test the hypothesis that use of spinal versus general anesthesia decreases the risk of delirium after hip fracture surgery.

Conditions

Postoperative Complications; Hip Fracture; Delirium

Keywords

delirium; hip fracture; general anesthesia; spinal anesthesia; postoperative complications

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Delirium After Hip Fracture Surgery

  Delirium will be assessed by the Confusion Assessment Method Instrument (CAM), a validated method of assessing delirium based on the presence of both (1) an acute onset of signs and symptoms with a fluctuating course AND (2) inattention; PLUS (3) disorganized thinking OR (4) an altered level of consciousness.

  Up to 5 days post hip fracture surgery

Study Arms (2)

General endotracheal anesthesia

ACTIVE COMPARATOR

Standard care general endotracheal anesthesia

Other: General endotracheal anesthesia

Regional (spinal) anesthesia

ACTIVE COMPARATOR

Standard care spinal anesthesia

Other: Regional (spinal) Anesthesia

Interventions

General endotracheal anesthesia OTHER

General Anesthesia Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol.

General endotracheal anesthesia

Regional (spinal) Anesthesia OTHER

Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed.

Regional (spinal) anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is aged 18 and older.
• Subject is scheduled to undergo surgical treatment of an acute femoral neck or pertrochanteric hip fracture.
• Subject can speak English
• Subject has ability to sign informed consent

You may not qualify if:

• Subject has a pathological or periprosthetic fracture.
• Subject has concurrent conditions anticipated at the time of admission to require surgical treatment (e.g. multiple trauma, acute cholecystitis).
• Subject has severe cognitive impairment, as evidenced by a Montreal Cognitive Assessment Score (MOCA) of 15 or less.
• Subject has clinical findings of delirium prior to surgery, as evidenced by a positive Confusion Assessment Method (CAM) evaluation;
• Subject has contraindications to spinal anesthesia or volatile general anesthetics.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hosptial of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (21)

• American Psychiatric Association. Delirium, Dementia, and Amnestic and Other Cognitive Disorders. In: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision). Washington, D.C.: American Psychiatric Association; 2000.

  BACKGROUND

• Russo CA, Elixhauser A. Hospitalizations in the Elderly Population, 2003. 2006 May. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #6. Available from http://www.ncbi.nlm.nih.gov/books/NBK63501/

  PMID: 21938846 BACKGROUND

• Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24.

  PMID: 19347026 BACKGROUND

• Inouye SK, Rushing JT, Foreman MD, Palmer RM, Pompei P. Does delirium contribute to poor hospital outcomes? A three-site epidemiologic study. J Gen Intern Med. 1998 Apr;13(4):234-42. doi: 10.1046/j.1525-1497.1998.00073.x.

  PMID: 9565386 BACKGROUND

• Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available.

  PMID: 16540616 BACKGROUND

• Blackman DK, Kamimoto LA, Smith SM. Overview: surveillance for selected public health indicators affecting older adults--United States. MMWR CDC Surveill Summ. 1999 Dec 17;48(8):1-6.

  PMID: 10634268 BACKGROUND

• Hung WW, Egol KA, Zuckerman JD, Siu AL. Hip fracture management: tailoring care for the older patient. JAMA. 2012 May 23;307(20):2185-94. doi: 10.1001/jama.2012.4842.

  PMID: 22618926 BACKGROUND

• Marcantonio ER, Flacker JM, Michaels M, Resnick NM. Delirium is independently associated with poor functional recovery after hip fracture. J Am Geriatr Soc. 2000 Jun;48(6):618-24. doi: 10.1111/j.1532-5415.2000.tb04718.x.

  PMID: 10855596 BACKGROUND

• Parker MJ, Handoll HH, Griffiths R. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000521. doi: 10.1002/14651858.CD000521.pub2.

  PMID: 15494999 BACKGROUND

• Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.

  PMID: 22713634 BACKGROUND

• Sandby-Thomas M, Sullivan G, Hall JE. A national survey into the peri-operative anaesthetic management of patients presenting for surgical correction of a fractured neck of femur. Anaesthesia. 2008 Mar;63(3):250-8. doi: 10.1111/j.1365-2044.2007.05328.x.

  PMID: 18289230 BACKGROUND

• National Clinical Guideline Centre (UK). The Management of Hip Fracture in Adults [Internet]. London: Royal College of Physicians (UK); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK83014/

  PMID: 22420011 BACKGROUND

• Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. doi: 10.4065/mcp.2009.0469.

  PMID: 20042557 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

  PMID: 2240918 BACKGROUND

• Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. J Clin Epidemiol. 1999 Jan;52(1):19-26. doi: 10.1016/s0895-4356(98)00138-3.

  PMID: 9973070 BACKGROUND

• Simon R. Restricted randomization designs in clinical trials. Biometrics. 1979 Jun;35(2):503-12.

  PMID: 486683 BACKGROUND

• Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.

  PMID: 12421743 BACKGROUND

• KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.

  PMID: 14044222 BACKGROUND

• Inouye SK, Viscoli CM, Horwitz RI, Hurst LD, Tinetti ME. A predictive model for delirium in hospitalized elderly medical patients based on admission characteristics. Ann Intern Med. 1993 Sep 15;119(6):474-81. doi: 10.7326/0003-4819-119-6-199309150-00005.

  PMID: 8357112 BACKGROUND

• Kahan BC, Morris TP. Improper analysis of trials randomised using stratified blocks or minimisation. Stat Med. 2012 Feb 20;31(4):328-40. doi: 10.1002/sim.4431. Epub 2011 Dec 4.

  PMID: 22139891 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Hip Fractures; Delirium

Interventions

Amino Acid Motifs; Anesthesia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Protein Structural Elements; Protein Conformation; Molecular Conformation; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Protein Structure, Secondary; Anesthesia and Analgesia

Limitations and Caveats

This was a limited pilot study conducted to assess the feasibility of a larger randomized trial.

Results Point of Contact

• Title: Mark D Neuman
• Organization: University of Pennsylvania School of Medicine

neumanm@mail.med.upenn.edu

2157467468

Study Officials

• Mark D Neuman

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Critical Care

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 15, 2014
• Study Start: October 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 30, 2018
• Results First Posted: July 30, 2018

Record last verified: 2018-07

Locations

US (1)