Skip to main content
OpenTrials
Completed

NCT Number: NCT05427149

The Effect of Intrathecal Magnesium Sulfate on Shivering

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?

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Van yuzuncu Yıl University, Dursun Odabas Medical Center

Van, 65080, Turkey (Türkiye)

About this study

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:

  • Loss of thermoregulatory vasoconstriction below the block level,
  • The displacement of body temperature from the central to the periphery due to vasodilation,
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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)

Primary outcomes

  1. 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,

    • = 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

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2022
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.