Skip to main content
OpenTrials
Completed

NCT Number: NCT02360982

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 fentanyl

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).

Primary outcomes

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

    Time frame: one year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Cukurova University Faculty of Medicine

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 11, 2015
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.