The Effect of Intrathecal Magnesium Sulfate on Shivering

September 23, 2022 updated by: Nureddin YUZKAT, Yuzuncu Yıl University

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Van, Turkey, 65080
        • Van Yüzüncü Yıl University, Dursun Odabaş Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group C
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)
It will be evaluated whether there is postpinal shivering in the cases.
Other Names:
  • 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)
Active Comparator: Group M25
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)
It will be evaluated whether there is postpinal shivering in the cases.
Other Names:
  • 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)
Active Comparator: Group M50
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)
It will be evaluated whether there is postpinal shivering in the cases.
Other Names:
  • 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)
Active Comparator: Group M100
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)
It will be evaluated whether there is postpinal shivering in the cases.
Other Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of shivering
Time Frame: 3 mounths

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Investigators

  • Principal Investigator: NUREDDİN YUZKAT, Assoc. prof, Van Yuzuncu Yil University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intrathecal magnesium sulfate

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Study protocol and statistical analysis plan wil be share other researchers

IPD Sharing Time Frame

6 mounth

IPD Sharing Access Criteria

The access can be provided via the e-mail addresses below nyuzkat@gmail.com

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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