Clinical trial NCT05427149: The Effect of Intrathecal Magnesium Sulfate on Shivering
Official title: The Effect of Different Doses of Intrathecal Magnesium Sulfate on Shivering After Spinal Anesthesia in Cesarean Sections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnesium Sulfate Causing Adverse Effects in Therapeutic Use
Postoperative Shivering
Cesarean Section Complications
Keywords: Bupivacaine
cesarean section
intrathecal magnesium sulfate
shivering
spinal anesthesia
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of shivering
timeFrame: 3 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van yuzuncu Yıl University, Dursun Odabas Medical Center
Study officials:
affiliation: VAN YUZUNCU YIL UNİVERSİTY
name: NUREDDİN YUZKAT, Assoc. prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.