The Effect of Intrathecal Magnesium Sulfate on Shivering

Yuzuncu Yıl University

Status: Completed

Conditions: Cesarean Section Complications; Magnesium Sulfate Causing Adverse Effects in Therapeutic Use; Postoperative Shivering

Treatments: Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)

Study type: Interventional

Funder types: Other

Identifiers

NCT05427149

Intrathecal magnesium sulfate

Details and patient eligibility

About

Shivering after spinal anesthesia is a common complication. Mangesium sulfate, which can be used intrathecally, is effective in preventing tremor. But what is the ideal dose?

Full description

Perioperative shivering during cesarean section (CS) under neuraxial anesthesia (NA) is clinically common, but its treatment is often neglected.

When the literature is scanned, perioperative tremors are seen in 55%-60% of patients undergoing neuraxial anesthesia. However, the mechanism of the tremor has not been fully elucidated. Possible factors that can cause tremor can be listed as follows:

1. Loss of thermoregulatory vasoconstriction below the block level,
2. The displacement of body temperature from the central to the periphery due to vasodilation,
3. Increased sweating threshold and decreased peripheral vasoconstriction Perioperative shivering is a complication that needs to be treated because it causes dangerous consequences in patients with low cardiopulmonary reserve due to increased oxygen consumption and impairs patient and surgeon comfort.

Magnesium sulfate is one of the most effective adjuvant drugs with the least side-effect profile in the treatment of tremor after noxial block.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Who were scheduled for elective C/S under SA,
• 18-40 years of age
• ASA physical status I-II.

Exclusion criteria

• Any contraindications to SA,
• preoperative body temperature >38 C,
• allergy to any drug used in the study,
• pre-eclampsia, and eclampsia,
• neuropathy,
• respiratory distress,
• coagulopathy, and
• any possible drugs that can change body temperature,
• ASA physical status > II.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Group C

Active Comparator group

Description:

Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 1 mL normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey)

Treatment:

Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)

Group M25

Active Comparator group

Description:

Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 25mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey).

Treatment:

Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)

Group M50

Active Comparator group

Description:

Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 50 mg/mL MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 50mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey).

Treatment:

Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)

Group M100

Active Comparator group

Description:

Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 100mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey)

Treatment:

Drug: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)