The Effect of Intrathecal Magnesium Sulfate on Shivering

Study Overview
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Brief Summary
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Shivering after spinal anesthesia is a common complication. Mangesium sulfate, which can be used intrathecally, is effective in preventing tremor. But what is the ideal dose?

Detailed Description
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Perioperative shivering during cesarean section (CS) under neuraxial anesthesia (NA) is clinically common, but its treatment is often neglected. 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: Loss of thermoregulatory vasoconstriction below the block level, The displacement of body temperature from the central to the periphery due to vasodilation, 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.

Official Title
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The Effect of Different Doses of Intrathecal Magnesium Sulfate on Shivering After Spinal Anesthesia in Cesarean Sections

Conditions
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Magnesium Sulfate Causing Adverse Effects in Therapeutic Use, Postoperative Shivering, Cesarean Section Complications

Intervention / Treatment
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* Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Who were scheduled for elective C/S under SA, 18-40 years of age ASA physical status I-II. Exclusion Criteria: Any contraindications to SA, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group C<br>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) | Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)<br>* It will be evaluated whether there is postpinal shivering in the cases.<br>* Other names: 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey);|
| Active Comparator: Group M25<br>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). | Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)<br>* It will be evaluated whether there is postpinal shivering in the cases.<br>* Other names: 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey);|
| Active Comparator: Group M50<br>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). | Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)<br>* It will be evaluated whether there is postpinal shivering in the cases.<br>* Other names: 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey);|
| Active Comparator: Group M100<br>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) | Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)<br>* It will be evaluated whether there is postpinal shivering in the cases.<br>* Other names: 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of shivering | Intraoperative and postoperative shivering will be evaluated with the shivering test established by Crossley and Mahajan. flicker tracking; The parameters looked at in this test approved by Crossley and Mahajan are: 0 = no flicker, = Piloerection or peripheral vasoconstriction, but no visible shivering, = Muscle activity in only 1 muscle group, = more muscle activity than 1 muscle group but not generalized = Full body shivering | 3 mounths | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, cesarean section, intrathecal magnesium sulfate, shivering, spinal anesthesia