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

February 6, 2015 updated by: ILKE KUPELI, Cukurova University

Cukurova University Faculty of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the presence of postoperative delirium as defined by CAM criteria.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
severity of delirium rated with the DRS-R-9
Time Frame: one year
one year
length of hospital stay and costs.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Estimate)

February 11, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cukurova University (Other Identifier: Cukurova University)

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