NCT02360982

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

February 4, 2015

Last Update Submit

February 6, 2015

Conditions

Postoperative Delirium

Keywords

Deliriumregional anesthesiageneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • the presence of postoperative delirium as defined by CAM criteria.

    one year

Secondary Outcomes (2)

  • severity of delirium rated with the DRS-R-9

    one year

  • length of hospital stay and costs.

    one year

Study Arms (2)

propofol and esmeron(rokuronyum)

In group G, anesthesia was induced with iv propofol (2 mg.kg-1) and maintained with 2% sevoflurane in a mixture of 65 % nitrous oxide and 35 % oxygen with a total gas flow rate of 6 L min-1. Neuromuscular relaxation was induced with iv rocuronium (esmeron) (0.5 mg.kg-1). Intravenous infusion of 0.9% saline was administered at a volume of 5 mL/kg/h. Patients received morphine (0.1mg/kg) for postoperative analgesia 30 minutes before the end of the operation. Anesthesia was terminated and neuromuscular blockade was antagonized with neostigmine (0.05 mg.kg-1)and atropine sulphate (0.01 mg.kg-1).

Behavioral: propofol and esmeron(rokuronyum)Behavioral: marcaine and fentanyl

marcaine and fentanyl

We inserted a 18-G Tuohy needle at the L3/L4 or L2/L3 intervertebral epidural space using an epidural loss of resistance technique and thus performed needle-through-needle technique for subarachnoid injection of 2 mL bupivacaine (marcaine)(0.5%) and fentanyl (25 mcg) by 27-G spinal needle. After subarachnoid injection, epidural catheter was advanced and fixed. At the end of the surgery 5 mL of bupivacaine 0.5% plus morphine (1 mg), adding to 4 mL saline was injected via epidural catheter for postoperative analgesia.Epidural catheter was removed at 24th hours

Behavioral: propofol and esmeron(rokuronyum)Behavioral: marcaine and fentanyl

Interventions

propofol and esmeron(rokuronyum)BEHAVIORAL

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 fentanylpropofol and esmeron(rokuronyum)
marcaine and fentanylBEHAVIORAL

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 fentanylpropofol and esmeron(rokuronyum)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

American Society of Anesthesiologists physical status I-III, 120 patients aged ≥65 years scheduled for total hip or knee arthroplasty and femur fracture surgery were enrolled into the study.

You may qualify if:

  • American Society of Anesthesiologists physical status I-III,
  • patients aged ≥65 years scheduled for total hip or knee arthroplasty and femur fracture surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (21)

  • 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. doi: 10.1016/s0163-8343(01)00117-7.

    PMID: 11313076BACKGROUND

  • 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.

    PMID: 18332845BACKGROUND

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

    PMID: 21785356BACKGROUND

  • 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.

    PMID: 23992774BACKGROUND

  • 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: 16540616BACKGROUND

  • 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. doi: 10.1007/BF03021625.

    PMID: 16803914BACKGROUND

  • 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.

    PMID: 19690943BACKGROUND

  • 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. doi: 10.1017/s0265021505000840.

    PMID: 16045136BACKGROUND

  • 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: 20042557BACKGROUND

  • 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. doi: 10.1046/j.1532-5415.2002.50210.x.

    PMID: 12028171BACKGROUND

  • 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.

    PMID: 20069607BACKGROUND

  • 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.

    PMID: 19106695BACKGROUND

  • 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.

    PMID: 18374970BACKGROUND

  • 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. doi: 10.1016/s0897-1897(03)00012-0.

    PMID: 12764718BACKGROUND

  • Martin NJ, Stones MJ, Young JE, Bedard M. Development of delirium: a prospective cohort study in a community hospital. Int Psychogeriatr. 2000 Mar;12(1):117-27. doi: 10.1017/s1041610200006244.

    PMID: 10798458BACKGROUND

  • Radtke FM, Franck M, MacGuill M, Seeling M, Lutz 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.

    PMID: 19887950BACKGROUND

  • 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. doi: 10.1093/gerona/58.1.m76.

    PMID: 12560416BACKGROUND

  • 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. doi: 10.1097/00000539-199804000-00019.

    PMID: 9539601BACKGROUND

  • 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.

    PMID: 19118253BACKGROUND

  • 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. doi: 10.1046/j.1525-1497.1998.00047.x.

    PMID: 9541379BACKGROUND

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

    PMID: 20007989RESULT

MeSH Terms

Conditions

Emergence DeliriumDelirium

Interventions

PropofolBupivacaineFentanyl

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnilidesAmidesAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • ILKE KUPELI

    MENGUCEK GAZI TRAINING AND RESEARCH HOSPITAL DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE

    PRINCIPAL INVESTIGATOR

  • ERSEL GULEC

    CUKUROVA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE

    STUDY CHAIR

  • EBRU BIRICIK

    CUKUROVA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE

    STUDY CHAIR

  • AKIF MIRIOĞLU

    CUKUROVA UNIVERSITY DEPARTMENT OF ORTHOPEDICS AND TRAUMATOLOGY

    STUDY CHAIR

  • YASEMIN GUNES

    CUKUROVA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist dr

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 11, 2015

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

February 11, 2015

Record last verified: 2015-02