Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section
Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section: A Comparative Study
Spinal anesthesia is widely used for cesarean deliveries, but shivering is a frequent complication that occurs in 40% to 60% of patients. Post-spinal shivering can cause maternal discomfort, increase oxygen consumption and metabolic demands, and interfere with clinical monitoring. Both paracetamol and magnesium sulfate have thermoregulatory properties that may prevent or reduce shivering.
The purpose of this clinical trial is to compare the efficacy and safety of intravenous paracetamol versus intravenous magnesium sulfate in preventing and reducing shivering following spinal anesthesia in women undergoing elective cesarean section.
A total of 90 pregnant women scheduled for elective cesarean delivery will be randomly assigned to one of two groups:
- Group P (Paracetamol Group): Participants receive intravenous paracetamol (15 mg/kg) infused over 15 minutes immediately following the subarachnoid block.
- Group M (Magnesium Sulfate Group): Participants receive intravenous magnesium sulfate (30 mg/kg) administered immediately following the subarachnoid block.
The primary outcome evaluated is the severity of post-spinal shivering assessed by shivering scores. Secondary outcomes include hemodynamic parameters (heart rate, blood pressure, oxygen saturation), postoperative pain, complications such as nausea and vomiting, and maternal satisfaction.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status class I or II
- Pregnant women aged 20 to 40 years
- Term gestation (>= 37 weeks) with an uncomplicated pregnancy
- Scheduled for elective cesarean delivery under planned spinal anesthesia
- Patient agreement and signed written informed consent
Exclusion Criteria:
- Patient refusal
- Morbid obesity (BMI > 35 kg/m²)
- Contraindications to spinal anesthesia
- Significant organ dysfunction (e.g., cardiac, respiratory, renal, or hepatic disorders)
- Known hypersensitivity or allergy to paracetamol or magnesium sulfate
- Cardiovascular or neuromuscular disorders in which magnesium administration is contraindicated
- Emergency cesarean section
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group P: Paracetamol Group
Participants receive intravenous paracetamol at a dose of 15 mg/kg infused over 15 minutes immediately after the completion of the subarachnoid block. |
Administered intravenously at a dose of 15 mg/kg infused over 15 minutes immediately after the completion of the subarachnoid block. |
|
Active Comparator: Group M: Magnesium Sulfate Group
Participants receive intravenous magnesium sulfate at a dose of 30 mg/kg administered immediately after the completion of the subarachnoid block. |
Administered intravenously at a dose of 30 mg/kg immediately after the completion of the subarachnoid block. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-Spinal Shivering Score
Time Frame: Up to 2 hours postoperatively
|
Post-spinal shivering severity is assessed using a 5-point shivering scale where Grade 0 indicates no shivering; Grade 1 indicates piloerection or peripheral vasoconstriction without visible shivering; Grade 2 indicates muscular activity in only one muscle group; Grade 3 indicates muscular activity in more than one muscle group, but not generalized; and Grade 4 indicates generalized, whole-body shivering. Total scores range from 0 to 4, with higher scores representing greater shivering severity |
Up to 2 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Paracetamol vs MgSO4 for CS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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