Influence of Intrathecal Dexamethasone Administration for Proximal Femoral Fractures
NCT ID: NCT03856502
Last Updated: 2019-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2012-11-11
2017-07-04
Brief Summary
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Intrathecal dexamethasone administration improves quality of anesthesia in patients with femur fracture compared to conventional spinal anesthesia.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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group that received dexamethasone (DLSA)
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.
8 mg of dexamethasone
Effect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture.
12,5 mg of 0,5 % of levobupivacaine
Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.
group without dexamethasone (LSA)
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.
12,5 mg of 0,5 % of levobupivacaine
Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.
Interventions
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8 mg of dexamethasone
Effect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture.
12,5 mg of 0,5 % of levobupivacaine
Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* agreed to be enrolled in the study (Informed Consent signed)
Exclusion Criteria
* 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
50 Years
100 Years
ALL
No
Sponsors
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General Hospital Sveti Duh
OTHER
Responsible Party
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Livija Šakić, MD,PhD
MD,PhD Anesthesiology, Reanimatology and Intensive Medicine
Principal Investigators
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Livija Šakić, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Sveti Duh
Locations
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University Hospital "Sveti Duh"
Zagreb, , Croatia
Countries
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References
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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.
Membership 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.
Borgeat 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.
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Desborough 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.
Hogevold 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.
Kehlet H. Manipulation of the metabolic response in clinical practice. World J Surg. 2000 Jun;24(6):690-5. doi: 10.1007/s002689910111.
Bani-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.
Kroin 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.
Yao 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.
Dong 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.
Williams 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.
Benzon 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.
Kopacz DJ, Lacouture PG, Wu D, Nandy P, Swanton R, Landau C. The dose response and effects of dexamethasone on bupivacaine microcapsules for intercostal blockade (T9 to T11) in healthy volunteers. Anesth Analg. 2003 Feb;96(2):576-82, table of contents. doi: 10.1097/00000539-200302000-00050.
Macro M, Reznik Y, Leymarie P, Loyau G, Mahoudeau J. The effect of intrathecal dexamethasone injection on plasma cortisol level. Br J Rheumatol. 1991 Jun;30(3):238. doi: 10.1093/rheumatology/30.3.238. No abstract available.
Bjorkelund KB, Hommel A, Thorngren KG, Gustafson L, Larsson S, Lundberg D. Reducing delirium in elderly patients with hip fracture: a multi-factorial intervention study. Acta Anaesthesiol Scand. 2010 Jul;54(6):678-88. doi: 10.1111/j.1399-6576.2010.02232.x. Epub 2010 Mar 15.
Rasmussen LS, O'Brien JT, Silverstein JH, Johnson TW, Siersma VD, Canet J, Jolles J, Hanning CD, Kuipers HM, Abildstrom H, Papaioannou A, Raeder J, Yli-Hankala A, Sneyd JR, Munoz L, Moller JT; ISPOCD2 Investigators. Is peri-operative cortisol secretion related to post-operative cognitive dysfunction? Acta Anaesthesiol Scand. 2005 Oct;49(9):1225-31. doi: 10.1111/j.1399-6576.2005.00791.x.
Mouzopoulos G, Vasiliadis G, Lasanianos N, Nikolaras G, Morakis E, Kaminaris M. Fascia iliaca block prophylaxis for hip fracture patients at risk for delirium: a randomized placebo-controlled study. J Orthop Traumatol. 2009 Sep;10(3):127-33. doi: 10.1007/s10195-009-0062-6. Epub 2009 Aug 19.
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Huang YF, Liang J, Shyu YL. Number of Comorbidities Negatively Influence Psychological Outcomes of the Elderly Following Hip Fracture in Taiwan. J Aging Health. 2016 Dec;28(8):1343-1361. doi: 10.1177/0898264315618922. Epub 2016 Jul 8.
Drews T, Franck M, Radtke FM, Weiss B, Krampe H, Brockhaus WR, Winterer G, Spies CD. Postoperative delirium is an independent risk factor for posttraumatic stress disorder in the elderly patient: a prospective observational study. Eur J Anaesthesiol. 2015 Mar;32(3):147-51. doi: 10.1097/EJA.0000000000000107.
Le Manach Y, Collins G, Bhandari M, Bessissow A, Boddaert J, Khiami F, Chaudhry H, De Beer J, Riou B, Landais P, Winemaker M, Boudemaghe T, Devereaux PJ. Outcomes After Hip Fracture Surgery Compared With Elective Total Hip Replacement. JAMA. 2015 Sep 15;314(11):1159-66. doi: 10.1001/jama.2015.10842.
Study Documents
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Document Type: Individual Participant Data Set
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View DocumentDocument Type: Individual Participant Data Set
View DocumentOther Identifiers
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662809198348
Identifier Type: -
Identifier Source: org_study_id