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Trial record 4 of 6 for:    20042557 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02360982
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
ILKE KUPELI, Cukurova University

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.

Condition or disease Intervention/treatment
Postoperative Delirium Behavioral: propofol and esmeron(rokuronyum) Behavioral: marcaine and fentanyl

Detailed 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.

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cukurova University Faculty of Medicine
Study Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
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)
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).

Behavioral: 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).

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)
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).

Behavioral: 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).




Primary Outcome Measures :
  1. the presence of postoperative delirium as defined by CAM criteria. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. severity of delirium rated with the DRS-R-9 [ Time Frame: one year ]
  2. length of hospital stay and costs. [ Time Frame: one year ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360982


Sponsors and Collaborators
Cukurova University
Investigators
Principal Investigator: ILKE KUPELI MENGUCEK GAZI TRAINING AND RESEARCH HOSPITAL DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE
Study Chair: 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

Publications of Results:
Other Publications:

Responsible Party: ILKE KUPELI, specialist dr, Cukurova University
ClinicalTrials.gov Identifier: NCT02360982     History of Changes
Other Study ID Numbers: cukurova university
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Keywords provided by ILKE KUPELI, Cukurova University:
Delirium
regional anesthesia
general anesthesia

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Anesthetics
Propofol
Fentanyl
Bupivacaine
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Local
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents