Clinical trial NCT02360982: The Comparison of Incidence and Risk Factors of Postoperative Delirium in Elderly Patients After Lower Extremity Surgery
Official title: Cukurova University Faculty of Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Keywords: Delirium
regional anesthesia
general anesthesia
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: the presence of postoperative delirium as defined by CAM criteria.
timeFrame: one year
Secondary outcomes:
measure: severity of delirium rated with the DRS-R-9
timeFrame: one year
measure: length of hospital stay and costs.
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: MENGUCEK GAZI TRAINING AND RESEARCH HOSPITAL DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE
name: ILKE KUPELI
role: PRINCIPAL_INVESTIGATOR
affiliation: CUKUROVA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE
name: ERSEL GULEC
role: STUDY_CHAIR
affiliation: CUKUROVA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE
name: EBRU BIRICIK
role: STUDY_CHAIR
affiliation: CUKUROVA UNIVERSITY DEPARTMENT OF ORTHOPEDICS AND TRAUMATOLOGY
name: AKIF MIRIOĞLU
role: STUDY_CHAIR
affiliation: CUKUROVA UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE
name: YASEMIN GUNES
role: STUDY_CHAIR
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