An interventional study of 8 mg of dexamethasone and 12,5 mg of 0,5 % of levobupivacaine in Femoral Fracture, Cognition Disorders and Cortisol; Hypersecretion, sponsored by General Hospital Sveti Duh. Completed at 1 site in Croatia. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-02-28.
Sponsored by General Hospital Sveti Duh · Not applicable, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 60 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →General Hospital Sveti Duh is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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The study group of 30 patients ASA status 2 or 3 received 8 mg of dexamethasone with 12,5 mg of 0,5% of levobupivacaine intrathecally for surgical reconstruction of proximal femoral fracture. Spinal anaesthesia was performed in sitting position using middle approach in intervertebral space L2-L3 or L3-L4 with spinal needles 22-27 GA.
Drug: 8 mg of dexamethasone · Drug: 12,5 mg of 0,5 % of levobupivacaine
The control group of 30 patients ASA status 2 or 3 received 12,5 mg of 0,5% of levobupivacaine intrathecally for surgical reconstruction of proximal femoral fracture. Spinal anaesthesia was performed in sitting position using middle approach in intervertebral space L2-L3 or L3-L4 with spinal needles 22-27 GA.
Drug: 12,5 mg of 0,5 % of levobupivacaine
Effect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture.
Also known as: Dexamethasone KRKA, Chirocaine Abbott
Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.
Also known as: Chirocaine Abbott
postoperative cognitive change
Assessed using a simplified Confusion Assessment Method scoring scale, a clinical instrument for delirium assessment used by non-psychiatric medical staff after surgery for excluding delirium. Delirium is defined in terms of 4 possible diagnostic criteria (1. acute onset or fluctuating course; 2- inattention; 3- disorganised thinking; 4- altered level of consciousness (may be defined as alert, lethargic, stupor or coma cognitive state)) and is defined as present when 1 plus 2 and either 3 or 4 diagnostic criteria are positive.
Time frame: 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
cortisol concentrations changes
Determined from patient's blood plasma assessed by Roche Elecsys Immunoassay System and defined from the laboratory reference points (185-624)nmol/L equal for each measure point; for single measuring 0,5 ml of patient's blood was taken
Time frame: 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
perioperative pain intensity: Visual Analogue Scale score
Assessed using Visual Analogue Scale score and establishing postoperative analgesic requirements
Time frame: 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
glucose concentrations changes
Determined form patient's blood plasma assessed by Beckman Coulter AU400 and AU680 orbOlympus Glucose Analyzer 2 devices defined from the laboratory reference points (4,4-6,4)mmol/L equal for each measure point; for single measuring 0,2 ml of patient's blood was taken
Time frame: 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
Blood loss
Determinated by intraoperative blood loss in mililitres, amount of blood in drainage systems in mililitres, transfusion of homologous blood in mililitres
Time frame: During the surgical repairment and up to the removal of drainage systems (2nd postoperative day)
Number of Participants with pulmonary embolism
Established by noted pulmonary embolism in the operating room or at the traumatology ward by the ward staff
Time frame: During surgical reconstruction and during postoperative follow-up of up to ten postoperative days
Number of Participants with heart failure
Established by noted heart failure in the operating room or at the traumatology ward by the ward staff
Time frame: During surgical reconstruction and during postoperative follow-up of up to ten postoperative days
Platelets changes
Determined from laboratory values of platelets data in reference points (158-424)10\^9/L equal for each measure point
Time frame: 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
Haemoglobin changes
Determined from laboratory values of haemoglobin data measured reference points (119-157)g/L equal for each measure point
Time frame: 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
Haematocrit changes
Determined from laboratory values of haematocrit data in reference points (0,356-0,470)L/L equal for each measure point
Time frame: 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
Hospitalisation
Calculated by number of days preoperatively from the day of admission to the day of surgical treatment and postoperatively from the day of surgical treatment to the day of hospital discharge
Time frame: In the time period of up to 30 days
Number of Participants who underwent surgical procedure during first 48 hours from admission
It was defined if surgical procedure was performed in first 48 hours from admission to the hospital's Emergency Department or later reflecting morbidity and/or mortality
Time frame: 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
Plan to share: No — The research has been a doctoral thesis.
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General Hospital Sveti Duh