Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate
Condition: Cesarean Section; Shivering
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Shivering is a common post-anesthetic complication occurring in up to 65% of patients
      undergoing spinal or epidural anesthesia. Shivering may interfere with electrocardiogram,
      blood pressure and oxygen saturation monitoring. In addition, shivering increases oxygen
      consumption, carbon dioxide production and metabolic rate by up to 400%. Thus, it may result
      in problems in patients with low cardiac and pulmonary reserves. Preventing shivering could
      therefore result in better postoperative outcomes or reduce the incidence of post-surgical
      complications.
    

Detailed description: 
      Magnesium sulfate (MgSO4) has anti-shivering effects. Moreover, it has potential
      neuroprotective effects and may enhance neuroprotection against the effects of hypothermia.
      Intrathecal MgSO4 administration provides effective perioperative analgesia and can prolong
      the period of anesthesia and sensory blockade without any additional side-effects. However,
      most of the research on the role of MgSO4 in the prevention of shivering has focused on
      intravenous infusion of this drug. Few clinical trials have examined the effect of adding
      intrathecal MgSO4 to anesthetic agents such as bupivacaine to suppress anesthesia-related
      shivering in patients. Similar to infusion studies, we hypothesized that the addition of
      intrathecal injection of MgSO4 to bupivacaine would improve perioperative shivering in female
      patients undergoing elective caesarean section. Few previous studies evaluated neuroaxial
      anti-shivering effects of intrathecal magnesium and none evaluated the anti-shivering effect
      of intrathecal MgSO4. Therefore, we elected to use the lowest dosage (25 mg MgSO4) that was
      formerly utilized for investigation of analgesic effects.

      Magnesium sulphate is an intracellular cation with various physiologic functions such as
      enzyme activation, nerve signal conduction, protein synthesis and vasomotor tonicity
      regulation. Magnesium sulphate has been used in various clinical situations including
      preeclampsia, tocolysis, arrhythmias, myocardial ischemia, bronchial asthma and postoperative
      shivering.
    

Intervention name(s): MgSo4; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomly allocated to one of two groups:
Group (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally.
Group(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally.; Patients will be randomly allocated to one of two groups:
Group (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally.
Group(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Shivering; Intrathecal; Magnesium Sulfate