The Effect of Intrathecal Magnesium Sulfate on Shivering
NCT ID: NCT05427149
Last Updated: 2022-09-27
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
120 participants
INTERVENTIONAL
2022-05-10
2022-08-30
Brief Summary
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Detailed Description
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When the literature is scanned, perioperative tremors are seen in 55%-60% of patients undergoing neuraxial anesthesia. However, the mechanism of the tremor has not been fully elucidated. Possible factors that can cause tremor can be listed as follows:
1. Loss of thermoregulatory vasoconstriction below the block level,
2. The displacement of body temperature from the central to the periphery due to vasodilation,
3. Increased sweating threshold and decreased peripheral vasoconstriction Perioperative shivering is a complication that needs to be treated because it causes dangerous consequences in patients with low cardiopulmonary reserve due to increased oxygen consumption and impairs patient and surgeon comfort.
Magnesium sulfate is one of the most effective adjuvant drugs with the least side-effect profile in the treatment of tremor after noxial block.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group C
Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 1 mL normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey)
25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)
It will be evaluated whether there is postpinal shivering in the cases.
Group M25
Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 25mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey).
25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)
It will be evaluated whether there is postpinal shivering in the cases.
Group M50
Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 50 mg/mL MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 50mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey).
25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)
It will be evaluated whether there is postpinal shivering in the cases.
Group M100
Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 100mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey)
25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)
It will be evaluated whether there is postpinal shivering in the cases.
Interventions
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25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)
It will be evaluated whether there is postpinal shivering in the cases.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-40 years of age
* ASA physical status I-II.
Exclusion Criteria
* preoperative body temperature \>38 C,
* allergy to any drug used in the study,
* pre-eclampsia, and eclampsia,
* neuropathy,
* respiratory distress,
* coagulopathy, and
* any possible drugs that can change body temperature,
* ASA physical status \> II.
18 Years
40 Years
FEMALE
No
Sponsors
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Yuzuncu Yıl University
OTHER
Responsible Party
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Nureddin YUZKAT
Assoc. proffesor
Principal Investigators
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NUREDDİN YUZKAT, Assoc. prof
Role: PRINCIPAL_INVESTIGATOR
VAN YUZUNCU YIL UNİVERSİTY
Locations
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Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van, , Turkey (Türkiye)
Countries
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References
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Ameta N, Jacob M, Hasnain S, Ramesh G. Comparison of prophylactic use of ketamine, tramadol, and dexmedetomidine for prevention of shivering after spinal anesthesia. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):352-356. doi: 10.4103/joacp.JOACP_211_16.
Hoshijima H, Takeuchi R, Kuratani N, Nishizawa S, Denawa Y, Shiga T, Nagasaka H. Incidence of postoperative shivering comparing remifentanil with other opioids: a meta-analysis. J Clin Anesth. 2016 Aug;32:300-12. doi: 10.1016/j.jclinane.2015.08.017. Epub 2015 Oct 1.
Jayaraj A, Balachander H, Kuppusamy SK, Arusamy S, Rai Y, Siddiqui N. Comparison of meperidine, tramadol and fentanyl for post-spinal shivering prevention during cesarean delivery: A double-blind randomized controlled trial. J Obstet Gynaecol Res. 2019 Nov;45(11):2202-2208. doi: 10.1111/jog.14106. Epub 2019 Sep 4.
Other Identifiers
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Intrathecal magnesium sulfate
Identifier Type: -
Identifier Source: org_study_id
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