Cognition Disorders Clinical Trial
Official title:
Impact of Intrathecal Dexamethasone Administration for Elderly Patients With Proximal Femoral Fracture
Verified date | February 2019 |
Source | General Hospital Sveti Duh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 4, 2017 |
Est. primary completion date | May 26, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital "Sveti Duh" | Zagreb |
Lead Sponsor | Collaborator |
---|---|
General Hospital Sveti Duh |
Croatia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | |
Primary | 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 | 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 | perioperative pain intensity: Visual Analogue Scale score | Assessed using Visual Analogue Scale score and establishing postoperative analgesic requirements | 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 | |
Secondary | 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 | 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 | |
Secondary | Blood loss | Determinated by intraoperative blood loss in mililitres, amount of blood in drainage systems in mililitres, transfusion of homologous blood in mililitres | During the surgical repairment and up to the removal of drainage systems (2nd postoperative day) | |
Secondary | Number of Participants with pulmonary embolism | Established by noted pulmonary embolism in the operating room or at the traumatology ward by the ward staff | During surgical reconstruction and during postoperative follow-up of up to ten postoperative days | |
Secondary | Number of Participants with heart failure | Established by noted heart failure in the operating room or at the traumatology ward by the ward staff | During surgical reconstruction and during postoperative follow-up of up to ten postoperative days | |
Secondary | Platelets changes | Determined from laboratory values of platelets data in reference points (158-424)10^9/L equal for each measure point | 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 | |
Secondary | Haemoglobin changes | Determined from laboratory values of haemoglobin data measured reference points (119-157)g/L equal for each measure point | 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 | |
Secondary | Haematocrit changes | Determined from laboratory values of haematocrit data in reference points (0,356-0,470)L/L equal for each measure point | 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 | |
Secondary | 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 | In the time period of up to 30 days | |
Secondary | 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 | 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 |
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