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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient refusal

Morbid obesity (BMI > 35 kg/m²)

Contraindications to spinal anesthesia

Significant organ dysfunction (e.g., cardiac, respiratory, renal, or hepatic disorders)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Group P: Paracetamol GroupActive comparator 1 intervention
Group B: Group M: Magnesium Sulfate GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-Spinal Shivering Score

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

Time frame
Up to 2 hours postoperatively

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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