Cesarean Section; Shivering Clinical Trial
Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
|Phase||Phase 2/Phase 3|
|Start date||June 2015|
|Completion date||December 2016|