The Effect of Intrathecal Magnesium Sulfate on Shivering

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427149
• Other study ID #: Intrathecal magnesium sulfate
• Status: Completed
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: August 30, 2022

Study information

• Verified date: September 2022
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)
It will be evaluated whether there is postpinal shivering in the cases.

Locations

Country	Name	City	State
Turkey	Van yuzuncu Yil University, Dursun Odabas Medical Center	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Ameta N, Jacob M, Hasnain S, Ramesh G. Comparison of prophylactic use of ketamine, tramadol, and dexmedetomidine for prevention of shivering after spinal anesthesia. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):352-356. doi: 10.4103/joacp.JOACP_211_16. — View Citation

Hoshijima H, Takeuchi R, Kuratani N, Nishizawa S, Denawa Y, Shiga T, Nagasaka H. Incidence of postoperative shivering comparing remifentanil with other opioids: a meta-analysis. J Clin Anesth. 2016 Aug;32:300-12. doi: 10.1016/j.jclinane.2015.08.017. Epub 2015 Oct 1. Review. — View Citation

Jayaraj A, Balachander H, Kuppusamy SK, Arusamy S, Rai Y, Siddiqui N. Comparison of meperidine, tramadol and fentanyl for post-spinal shivering prevention during cesarean delivery: A double-blind randomized controlled trial. J Obstet Gynaecol Res. 2019 Nov;45(11):2202-2208. doi: 10.1111/jog.14106. Epub 2019 Sep 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of shivering	Intraoperative 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,; = Piloerection or peripheral vasoconstriction, but no visible shivering,; = Muscle activity in only 1 muscle group,; = more muscle activity than 1 muscle group but not generalized; = Full body shivering	3 mounths