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

NCT07855588 | Not Yet Recruiting Phase 4

• 1 other identifier: Paracetamol vs MgSO4 for CS
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Shivering; Post-Spinal Shivering

Keywords

Paracetamol; Acetaminophen; Magnesium Sulfate; Spinal Anesthesia; Cesarean Section; Subarachnoid Block; Thermoregulation

Outcome Measures

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

  Up to 2 hours postoperatively

Study Arms (2)

Group P: Paracetamol Group

ACTIVE COMPARATOR

Participants receive intravenous paracetamol at a dose of 15 mg/kg infused over 15 minutes immediately after the completion of the subarachnoid block.

Drug: Paracetamol

Group M: Magnesium Sulfate Group

ACTIVE COMPARATOR

Participants receive intravenous magnesium sulfate at a dose of 30 mg/kg administered immediately after the completion of the subarachnoid block.

Drug: Magnesium Sulfate

Interventions

Paracetamol DRUG

Administered intravenously at a dose of 15 mg/kg infused over 15 minutes immediately after the completion of the subarachnoid block.

Group P: Paracetamol Group

Magnesium Sulfate DRUG

Administered intravenously at a dose of 30 mg/kg immediately after the completion of the subarachnoid block.

Group M: Magnesium Sulfate Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Acetaminophen; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09