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The Effect of Intrathecal Magnesium Sulfate on Shivering

The Effect of Different Doses of Intrathecal Magnesium Sulfate on Shivering After Spinal Anesthesia in Cesarean Sections

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05427149
Enrollment
120
Registered
2022-06-22
Start date
2022-05-10
Completion date
2022-08-30
Last updated
2022-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications, Magnesium Sulfate Causing Adverse Effects in Therapeutic Use, Postoperative Shivering

Keywords

Bupivacaine, cesarean section, intrathecal magnesium sulfate, shivering, spinal anesthesia

Brief summary

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?

Detailed 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.

Interventions

DRUG25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)

It will be evaluated whether there is postpinal shivering in the cases.

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Level of shivering3 mounthsIntraoperative and postoperative shivering will be evaluated with the shivering test established by Crossley and Mahajan. flicker tracking; The parameters looked at in this test approved by Crossley and Mahajan are: 0 = no flicker, 1. = Piloerection or peripheral vasoconstriction, but no visible shivering, 2. = Muscle activity in only 1 muscle group, 3. = more muscle activity than 1 muscle group but not generalized 4. = Full body shivering

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026