Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section

NCT07855588 — Phase 4, Not yet recruiting, 90 participants, Assiut University

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Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section: A Comparative Study

Registry	NCT07855588
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	90 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Shivering, Post-Spinal Shivering
Interventions	Paracetamol, Magnesium Sulfate (Drug)
Dates	start 2026-11-01 (estimated), primary completion 2027-11-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-10-02, last updated 2026-10-02

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group P: Paracetamol Group	Active comparator	Drug: Paracetamol	Participants receive intravenous paracetamol at a dose of 15 mg/kg infused over 15 minutes immediately after the completion of the subarachnoid block.
Group M: Magnesium Sulfate Group	Active comparator	Drug: Magnesium Sulfate	Participants receive intravenous magnesium sulfate at a dose of 30 mg/kg administered immediately after the completion of the subarachnoid block.

Paracetamol (Drug): Administered intravenously at a dose of 15 mg/kg infused over 15 minutes immediately after the completion of the subarachnoid block.
Magnesium Sulfate (Drug): Administered intravenously at a dose of 30 mg/kg immediately after the completion of the subarachnoid block.

+Outcome measures

Primary outcomes

Post-Spinal Shivering Score [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

+Eligibility

Sex: Female, ages: 20 Years to 40 Years

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