Femoral FractureNCT03856502
Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures
A study testing 8 mg of dexamethasone and 12,5 mg of 0,5 % of levobupivacaine in people with Femoral Fracture and Cognition Disorders, run by General Hospital Sveti Duh at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Femoral Fracture, Cognition Disorders, Cortisol; Hypersecretion
- What is being tested?
- 8 mg of dexamethasone and 12,5 mg of 0,5 % of levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 11 Nov 2012to 4 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Intrathecal Dexamethasone Administration for Elderly Patients With Proximal Femoral Fracture
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.
Read the 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.
- Being tested
- 8 mg of dexamethasone, 12,5 mg of 0,5 % of levobupivacaine
- Keywords
- spinal anesthesia, femoral fracture, dexamethasone
- Medical subject headings
- Femoral Fractures, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8 mg of dexamethasoneDrug
Also called Dexamethasone KRKA, Chirocaine Abbott
Effect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture.
12,5 mg of 0,5 % of levobupivacaineDrug
Also called Chirocaine Abbott
Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.
| Study group | Role | What they receive |
|---|---|---|
| group that received dexamethasone (DLSA) | Experimental | 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. Receives: Drug: 8 mg of dexamethasone; Drug: 12,5 mg of 0,5 % of levobupivacaine |
| group without dexamethasone (LSA) | Active comparator | 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. Receives: Drug: 12,5 mg of 0,5 % of levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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 (10)
perioperative pain intensity: Visual Analogue Scale score
Assessed using Visual Analogue Scale score and establishing postoperative analgesic requirements
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start11 Nov 2012
- Primary completion26 May 2016
- Study completion4 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Femoral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Sveti Duh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livija Šakić, MD,PhD, General Hospital Sveti Duh
- Investigators
- Livija Šakić, MD,PhD, Principal investigator, University Hospital Sveti Duh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856502
- Sponsor's protocol ID
- 662809198348
- Status last verified
- Feb 2019
- First submitted
- 2 Nov 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Individual data sharing
- No: The research has been a doctoral thesis.
Publications
Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.
PubMed 22713634Membership of the Working Party; Griffiths R, Alper J, Beckingsale A, Goldhill D, Heyburn G, Holloway J, Leaper E, Parker M, Ridgway S, White S, Wiese M, Wilson I. Management of proximal femoral fractures 2011: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2012 Jan;67(1):85-98. doi: 10.1111/j.1365-2044.2011.06957.x.
PubMed 22150501Borgeat A, Ekatodramis G. Orthopaedic surgery in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):235-44. doi: 10.1016/s1521-6896(03)00007-7.
PubMed 12817917Baumann H, Gauldie J. The acute phase response. Immunol Today. 1994 Feb;15(2):74-80. doi: 10.1016/0167-5699(94)90137-6.
PubMed 7512342Buckingham JC. Stress and the hypothalamo-pituitary-immune axis. Int J Tissue React. 1998;20(1):23-34. No abstract available.
PubMed 9561443Munck A, Guyre PM, Holbrook NJ. Physiological functions of glucocorticoids in stress and their relation to pharmacological actions. Endocr Rev. 1984 Winter;5(1):25-44. doi: 10.1210/edrv-5-1-25.
PubMed 6368214Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
PubMed 10927999Hogevold HE, Lyberg T, Kahler H, Haug E, Reikeras O. Changes in plasma IL-1beta, TNF-alpha and IL-6 after total hip replacement surgery in general or regional anaesthesia. Cytokine. 2000 Jul;12(7):1156-9. doi: 10.1006/cyto.2000.0675.
PubMed 10880268Kehlet H. Manipulation of the metabolic response in clinical practice. World J Surg. 2000 Jun;24(6):690-5. doi: 10.1007/s002689910111.
PubMed 10773121Bani-Hashem N, Hassan-Nasab B, Pour EA, Maleh PA, Nabavi A, Jabbari A. Addition of intrathecal Dexamethasone to Bupivacaine for spinal anesthesia in orthopedic surgery. Saudi J Anaesth. 2011 Oct;5(4):382-6. doi: 10.4103/1658-354X.87267.
PubMed 22144925Kroin JS, Schaefer RB, Penn RD. Chronic intrathecal administration of dexamethasone sodium phosphate: pharmacokinetics and neurotoxicity in an animal model. Neurosurgery. 2000 Jan;46(1):178-82; discussion 182-3.
PubMed 10626948Yao XL, Cowan MJ, Gladwin MT, Lawrence MM, Angus CW, Shelhamer JH. Dexamethasone alters arachidonate release from human epithelial cells by induction of p11 protein synthesis and inhibition of phospholipase A2 activity. J Biol Chem. 1999 Jun 11;274(24):17202-8. doi: 10.1074/jbc.274.24.17202.
PubMed 10358078Dong Y, Zhang X, Tang F, Tian X, Zhao Y, Zhang F. Intrathecal injection with methotrexate plus dexamethasone in the treatment of central nervous system involvement in systemic lupus erythematosus. Chin Med J (Engl). 2001 Jul;114(7):764-6.
PubMed 11780346Williams BA, Hough KA, Tsui BY, Ibinson JW, Gold MS, Gebhart GF. Neurotoxicity of adjuvants used in perineural anesthesia and analgesia in comparison with ropivacaine. Reg Anesth Pain Med. 2011 May-Jun;36(3):225-30. doi: 10.1097/AAP.0b013e3182176f70.
PubMed 21519308Benzon HT, Chew TL, McCarthy RJ, Benzon HA, Walega DR. Comparison of the particle sizes of different steroids and the effect of dilution: a review of the relative neurotoxicities of the steroids. Anesthesiology. 2007 Feb;106(2):331-8. doi: 10.1097/00000542-200702000-00022.
PubMed 17264728
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intrathecal Dexamethasone Administration for Elderly Patients With Proximal Femoral Fracture
- ClinicalTrials.gov ID
- NCT03856502
- Acronym / sponsor ID
- 662809198348
- Keywords
- spinal anesthesia, femoral fracture, dexamethasone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- General Hospital Sveti DuhUniversity, hospital or other
- Study start
- 11 Nov 2012 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 4 Jul 2017 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group that received dexamethasone (DLSA) | Experimental | Drug: 8 mg of dexamethasone, Drug: 12,5 mg of 0,5 % of levobupivacaineThe 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. |
| group without dexamethasone (LSA) | Active comparator | Drug: 12,5 mg of 0,5 % of levobupivacaineThe 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. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8 mg of dexamethasoneAlso: Dexamethasone KRKA, Chirocaine AbbottEffect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture. | Drug | group that received dexamethasone (DLSA) |
| 12,5 mg of 0,5 % of levobupivacaineAlso: Chirocaine AbbottLocal anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol. | Drug | group that received dexamethasone (DLSA), group without dexamethasone (LSA) |
Primary outcome
postoperative cognitive change
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
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.
cortisol concentrations changes
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
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
10 secondary outcomes
perioperative pain intensity: Visual Analogue Scale score
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
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
Time frame: During the surgical repairment and up to the removal of drainage systems (2nd postoperative day)
Number of Participants with pulmonary embolism
Time frame: During surgical reconstruction and during postoperative follow-up of up to ten postoperative days
Number of Participants with heart failure
Time frame: During surgical reconstruction and during postoperative follow-up of up to ten postoperative days
Platelets changes
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
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
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
Time frame: In the time period of up to 30 days
Number of Participants who underwent surgical procedure during first 48 hours from admission
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Background: PubMed 22713634Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.
- Background: PubMed 22150501Membership of the Working Party; Griffiths R, Alper J, Beckingsale A, Goldhill D, Heyburn G, Holloway J, Leaper E, Parker M, Ridgway S, White S, Wiese M, Wilson I. Management of proximal femoral fractures 2011: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2012 Jan;67(1):85-98. doi: 10.1111/j.1365-2044.2011.06957.x.
- Background: PubMed 12817917Borgeat A, Ekatodramis G. Orthopaedic surgery in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):235-44. doi: 10.1016/s1521-6896(03)00007-7.
- Background: PubMed 7512342Baumann H, Gauldie J. The acute phase response. Immunol Today. 1994 Feb;15(2):74-80. doi: 10.1016/0167-5699(94)90137-6.
- Background: PubMed 9561443Buckingham JC. Stress and the hypothalamo-pituitary-immune axis. Int J Tissue React. 1998;20(1):23-34. No abstract available.
- Background: PubMed 6368214Munck A, Guyre PM, Holbrook NJ. Physiological functions of glucocorticoids in stress and their relation to pharmacological actions. Endocr Rev. 1984 Winter;5(1):25-44. doi: 10.1210/edrv-5-1-25.
- Background: PubMed 10927999Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
- Background: PubMed 10880268Hogevold HE, Lyberg T, Kahler H, Haug E, Reikeras O. Changes in plasma IL-1beta, TNF-alpha and IL-6 after total hip replacement surgery in general or regional anaesthesia. Cytokine. 2000 Jul;12(7):1156-9. doi: 10.1006/cyto.2000.0675.
- Background: PubMed 10773121Kehlet H. Manipulation of the metabolic response in clinical practice. World J Surg. 2000 Jun;24(6):690-5. doi: 10.1007/s002689910111.
- Background: PubMed 22144925Bani-Hashem N, Hassan-Nasab B, Pour EA, Maleh PA, Nabavi A, Jabbari A. Addition of intrathecal Dexamethasone to Bupivacaine for spinal anesthesia in orthopedic surgery. Saudi J Anaesth. 2011 Oct;5(4):382-6. doi: 10.4103/1658-354X.87267.
- Background: PubMed 10626948Kroin JS, Schaefer RB, Penn RD. Chronic intrathecal administration of dexamethasone sodium phosphate: pharmacokinetics and neurotoxicity in an animal model. Neurosurgery. 2000 Jan;46(1):178-82; discussion 182-3.
- Background: PubMed 10358078Yao XL, Cowan MJ, Gladwin MT, Lawrence MM, Angus CW, Shelhamer JH. Dexamethasone alters arachidonate release from human epithelial cells by induction of p11 protein synthesis and inhibition of phospholipase A2 activity. J Biol Chem. 1999 Jun 11;274(24):17202-8. doi: 10.1074/jbc.274.24.17202.
- Individual participant dataSharing planned: No. The research has been a doctoral thesis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Livija Šakić, MD,PhD principal investigator
University Hospital Sveti Duh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8 mg of dexamethasone and 12,5 mg of 0,5 % of levobupivacaine in people with Femoral Fracture and Cognition Disorders, run by General Hospital Sveti Duh at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative cognitive change (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03856502, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.