Clinical trial NCT03856502: Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures
Official title: Impact of Intrathecal Dexamethasone Administration for Elderly Patients With Proximal Femoral Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Fracture
Cognition Disorders
Cortisol; Hypersecretion
Keywords: spinal anesthesia
femoral fracture
dexamethasone
Lead sponsor: General Hospital Sveti Duh
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spinal anesthesia blocks acute pain in older patients with femur fracture. Delirium is a common complication seen after femur fracture, affecting approximately 10-16% of patients. It is associated with increased mortality at 1st year, delayed rehabilitation efforts, prolonged length of hospital stay, poorer functional outcomes, and increased risk of nursing home placement.

Intrathecal dexamethasone administration improves quality of anesthesia in patients with femur fracture compared to conventional spinal anesthesia.

Detailed description: The aim of this research was to establish the influence of intrathecal dexamethasone administration in spinal anaesthesia with levobupivacaine on postoperative pain and changes of consciousness, values of cortisol levels and quality of treatment for patients with femoral fractures compared to spinal anaesthesia with only local anaesthetic.

The study was planned as a prospective, observational, randomised clinical trial. A total of 60 patients ASA2 and ASA3 status, scheduled for surgical procedures were sorted into two groups and underwent surgery in spinal anesthesia with levobupivacaine with or without dexamethsone.

Eligibility criteria: Inclusion Criteria:

* cooperative ASA 2 and ASA 3 status patients with proximal femoral fractures of one leg
* agreed to be enrolled in the study (Informed Consent signed)

Exclusion Criteria:

* patients refused to be enrolled in the study
* patients with pre-existing cognitive disturbances before surgery
* conditions or diseases with corticosteroid therapy, long term corticosteroid, diabetes mellitus, neurological conditions or tumors, neuroendocrine disorders or tumors
* breaking the study protocols
* patients who no longer wanted to be enrolled in the study
* unexpected events when the study already started

Primary outcomes:
measure: postoperative cognitive change
timeFrame: Confusion Assessment Method scoring was assessed in 4 measure points: 1. one hour after surgery, 2. on the 3rd postoperative day at 9 am, 3. on the 5th postoperative day at 9 am, 4. on the 10th postoperative day at 9 am
measure: cortisol concentrations changes
timeFrame: Measured in 5 measure points: 1. one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am
Secondary outcomes:
measure: perioperative pain intensity: Visual Analogue Scale score
timeFrame: Visual Analogue Scale scoring (scores: 0-10) was assessed in 5 measure points every 3 hours when patient was awake: 1. 1 h before surgery, 2. 1 h after surgery, 3. on the 3rd postoperative day, 4. on the 5th postoperative day, 5. 10th postoperative day
measure: glucose concentrations changes
timeFrame: Measured in 5 measure points (units: mmol/L): 1. one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am
measure: Blood loss
timeFrame: During the surgical repairment and up to the removal of drainage systems (2nd postoperative day)
measure: Number of Participants with pulmonary embolism
timeFrame: During surgical reconstruction and during postoperative follow-up of up to ten postoperative days
measure: Number of Participants with heart failure
timeFrame: During surgical reconstruction and during postoperative follow-up of up to ten postoperative days
measure: Platelets changes
timeFrame: Assessed in 5 measure points: 1.one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am
measure: Haemoglobin changes
timeFrame: Assessed in 5 measure points: 1.one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am
measure: Haematocrit changes
timeFrame: Assessed in 5 measure points: 1.one hour before surgery, 2. one hour after surgery, 3. on the 3rd postoperative day at 6 am, 4. on the 5th postoperative day at 6 am, 5. on the 10th postoperative day at 6 am
measure: Hospitalisation
timeFrame: In the time period of up to 30 days
measure: Number of Participants who underwent surgical procedure during first 48 hours from admission
timeFrame: Calculated in hours after the patient's admission to the hospital's Emergency Department to the point of surgical reconstruction in the time period up to 48 hours
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital "Sveti Duh"
Study officials:
affiliation: University Hospital Sveti Duh
name: Livija Šakić, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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