The Effect of Intrathecal Magnesium Sulfate on Shivering

NCT05427149 | Completed

• 1 other identifier: Intrathecal magnesium sulfate
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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, 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

  3 mounths

Study Arms (4)

Group C

ACTIVE COMPARATOR

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)

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

Group M25

ACTIVE COMPARATOR

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).

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

Group M50

ACTIVE COMPARATOR

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).

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

Group M100

ACTIVE COMPARATOR

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)

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

Interventions

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

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

Also known as: 50 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey), 75 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey), 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)

Group C; Group M100; Group M25; Group M50

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: The study will be carried out on pregnant cases who will undergo cesarean section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van yuzuncu Yıl University, Dursun Odabas Medical Center

Van, 65080, Turkey (Türkiye)

Location

Related 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.

  PMID: 30386019 BACKGROUND

• 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.

  PMID: 26432635 BACKGROUND

• 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.

  PMID: 31486253 BACKGROUND

Study Officials

• NUREDDİN YUZKAT, Assoc. prof

  VAN YUZUNCU YIL UNİVERSİTY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. proffesor

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: June 22, 2022
• Study Start: May 10, 2022
• Primary Completion: June 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 mounth
• Access Criteria: The access can be provided via the e-mail addresses below nyuzkat@gmail.com

Locations

TU (1)