The Comparison of Incidence and Risk Factors of Postoperative Delirium in Elderly Patients After Lower Extremity Surgery

Postoperative Delirium Clinical Trial

Official title:

Cukurova University Faculty of Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360982
• Other study ID #: cukurova university
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: February 6, 2015
• Start date: March 2012
• Est. completion date: April 2013

Study information

• Verified date: February 2015
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The aim of this study is to compare the risk factors and the incidence of delirium following orthopedic surgery under the general or regional anesthesia in elderly patients.

Description:

One hundred twenty elderly patients aged ≥65 years scheduled for total hip or knee arthroplasty and femur fracture surgery were enrolled into the study. Patients were allocated into two groups to receive regional anesthesia (group R, n=50) or general anesthesia (group G, n=70). Hemodynamic and blood parameters, potential risk factors of delirium including age, sex, duration of surgery, the type of anesthesia, coexisting disease, smoking and amount of drug used delirium tests (CAM and DRS-R-98), hospital stay and costs were recorded for all patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status I-III,

• 120 patients aged =65 years scheduled for total hip or knee arthroplasty and femur fracture surgery

Exclusion Criteria:

• Exclusion criteria were patient refusal, abuse of alcohol and/or drugs

• Hypersensitivity to local anesthetics

• Vertebral abnormality

• Previous lumbar vertebra surgery

• Coagulation disorder

• Infection (systemic or local)

• Cerebrovascular disease

• Neurosurgery

• Vascular surgery

• Frequent use of analgesic drug

• =5 drugs per day and psychiatric medication

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Behavioral:
• propofol and esmeron(rokuronyum)
All patients were evaluated at postoperative 24th and 72th hours with laboratory tests including hemoglobin, sodium, potassium, BUN, creatinine, total protein, albumin and glucose values in blood samples and delirium tests (CAM and DRS-R-98).
• marcaine and fentanyl
All patients were evaluated at postoperative 24th and 72th hours with laboratory tests including hemoglobin, sodium, potassium, BUN, creatinine, total protein, albumin and glucose values in blood samples and delirium tests (CAM and DRS-R-98).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

References & Publications (21)

Ansaloni L, Catena F, Chattat R, Fortuna D, Franceschi C, Mascitti P, Melotti RM. Risk factors and incidence of postoperative delirium in elderly patients after elective and emergency surgery. Br J Surg. 2010 Feb;97(2):273-80. doi: 10.1002/bjs.6843. — View Citation

Bryson GL, Wyand A. Evidence-based clinical update: general anesthesia and the risk of delirium and postoperative cognitive dysfunction. Can J Anaesth. 2006 Jul;53(7):669-77. Review. — View Citation

Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1:i41-46. doi: 10.1093/bja/aep291. Review. — View Citation

Elie M, Cole MG, Primeau FJ, Bellavance F. Delirium risk factors in elderly hospitalized patients. J Gen Intern Med. 1998 Mar;13(3):204-12. — View Citation

Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28. Review. — View Citation

Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. Review. Erratum in: N Engl J Med. 2006 Apr 13;354(15):1655. — View Citation

Litaker D, Locala J, Franco K, Bronson DL, Tannous Z. Preoperative risk factors for postoperative delirium. Gen Hosp Psychiatry. 2001 Mar-Apr;23(2):84-9. — View Citation

Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. The impact of postoperative pain on the development of postoperative delirium. Anesth Analg. 1998 Apr;86(4):781-5. — View Citation

Marcantonio E, Ta T, Duthie E, Resnick NM. Delirium severity and psychomotor types: their relationship with outcomes after hip fracture repair. J Am Geriatr Soc. 2002 May;50(5):850-7. — View Citation

Martin NJ, Stones MJ, Young JE, Bédard M. Development of delirium: a prospective cohort study in a community hospital. Int Psychogeriatr. 2000 Mar;12(1):117-27. — View Citation

McAlpine JN, Hodgson EJ, Abramowitz S, Richman SM, Su Y, Kelly MG, Luther M, Baker L, Zelterman D, Rutherford TJ, Schwartz PE. The incidence and risk factors associated with postoperative delirium in geriatric patients undergoing surgery for suspected gynecologic malignancies. Gynecol Oncol. 2008 May;109(2):296-302. doi: 10.1016/j.ygyno.2008.02.016. Epub 2008 Mar 28. — View Citation

Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. — View Citation

Mouzopoulos G, Vasiliadis G, Lasanianos N, Nikolaras G, Morakis E, Kaminaris M. Fascia iliaca block prophylaxis for hip fracture patients at risk for delirium: a randomized placebo-controlled study. J Orthop Traumatol. 2009 Sep;10(3):127-33. doi: 10.1007/s10195-009-0062-6. Epub 2009 Aug 19. — View Citation

Papaioannou A, Fraidakis O, Michaloudis D, Balalis C, Askitopoulou H. The impact of the type of anaesthesia on cognitive status and delirium during the first postoperative days in elderly patients. Eur J Anaesthesiol. 2005 Jul;22(7):492-9. — View Citation

Radtke FM, Franck M, MacGuill M, Seeling M, Lütz A, Westhoff S, Neumann U, Wernecke KD, Spies CD. Duration of fluid fasting and choice of analgesic are modifiable factors for early postoperative delirium. Eur J Anaesthesiol. 2010 May;27(5):411-6. doi: 10.1097/EJA.0b013e3283335cee. — View Citation

Robinson TN, Raeburn CD, Tran ZV, Angles EM, Brenner LA, Moss M. Postoperative delirium in the elderly: risk factors and outcomes. Ann Surg. 2009 Jan;249(1):173-8. doi: 10.1097/SLA.0b013e31818e4776. — View Citation

Rudolph JL, Jones RN, Levkoff SE, Rockett C, Inouye SK, Sellke FW, Khuri SF, Lipsitz LA, Ramlawi B, Levitsky S, Marcantonio ER. Derivation and validation of a preoperative prediction rule for delirium after cardiac surgery. Circulation. 2009 Jan 20;119(2):229-36. doi: 10.1161/CIRCULATIONAHA.108.795260. Epub 2008 Dec 31. — View Citation

Schrader SL, Wellik KE, Demaerschalk BM, Caselli RJ, Woodruff BK, Wingerchuk DM. Adjunctive haloperidol prophylaxis reduces postoperative delirium severity and duration in at-risk elderly patients. Neurologist. 2008 Mar;14(2):134-7. doi: 10.1097/NRL.0b013e318166b88c. Review. — View Citation

Schuurmans MJ, Duursma SA, Shortridge-Baggett LM, Clevers GJ, Pel-Littel R. Elderly patients with a hip fracture: the risk for delirium. Appl Nurs Res. 2003 May;16(2):75-84. — View Citation

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. Erratum in: Mayo Clin Proc. 2010 Apr;85(4):400. Dosage error in article text. — View Citation

Steiner LA. Postoperative delirium. Part 1: pathophysiology and risk factors. Eur J Anaesthesiol. 2011 Sep;28(9):628-36. doi: 10.1097/EJA.0b013e328349b7f5. Review. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the presence of postoperative delirium as defined by CAM criteria.		one year	No
Secondary	severity of delirium rated with the DRS-R-9		one year	No
Secondary	length of hospital stay and costs.		one year	No