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NCT Number: NCT03008850

Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate

Shivering is a common post-anesthetic complication occurring in up to 65% of patients undergoing spinal or epidural anesthesia. Shivering may interfere with electrocardiogram, blood pressure and oxygen saturation monitoring. In addition, shivering increases oxygen consumption, carbon dioxide production and metabolic rate by up to 400%. Thus, it may result in problems in patients with low cardiac and pulmonary reserves. Preventing shivering could therefore result in better postoperative outcomes or reduce the incidence of post-surgical complications.

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Key information

Conditions

Cesarean Section; Shivering

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut university hospital

Asyut, Asyut Governorate, 71515, Egypt

About this study

Magnesium sulfate (MgSO4) has anti-shivering effects. Moreover, it has potential neuroprotective effects and may enhance neuroprotection against the effects of hypothermia. Intrathecal MgSO4 administration provides effective perioperative analgesia and can prolong the period of anesthesia and sensory blockade without any additional side-effects. However, most of the research on the role of MgSO4 in the prevention of shivering has focused on intravenous infusion of this drug. Few clinical trials have examined the effect of adding intrathecal MgSO4 to anesthetic agents such as bupivacaine to suppress anesthesia-related shivering in patients. Similar to infusion studies, we hypothesized that the addition of intrathecal injection of MgSO4 to bupivacaine would improve perioperative shivering in female patients undergoing elective caesarean section. Few previous studies evaluated neuroaxial anti-shivering effects of intrathecal magnesium and none evaluated the anti-shivering effect of intrathecal MgSO4. Therefore, we elected to use the lowest dosage (25 mg MgSO4) that was formerly utilized for investigation of analgesic effects.

Magnesium sulphate is an intracellular cation with various physiologic functions such as enzyme activation, nerve signal conduction, protein synthesis and vasomotor tonicity regulation. Magnesium sulphate has been used in various clinical situations including preeclampsia, tocolysis, arrhythmias, myocardial ischemia, bronchial asthma and postoperative shivering.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 to 35years.
  • Undergo elective cesarean section under spinal anesthesia.
  • ASA physical status I-II.
  • Singleton pregnancy.
  • At least 38 weeks gestation.

Exclusion criteria

  • Women with history of cardiac, liver or kidney diseases.
  • Women with allergy to amide local anesthetics or medication included in the study.
  • Women with any neurological problem.
  • Any contraindication of regional anesthesia.
  • Failed or insatisfactory spinal block.
  • Preoperative temperature more than 38⁰ C.

Treatment and study plan

MgSO4

Drug

Patients will be randomly allocated to one of two groups:

Group (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally.

Group(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally.

Placebo

Drug

Patients will be randomly allocated to one of two groups:

Group (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally.

Group(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally.

Primary outcomes

  1. Shivering Score

    Time frame: 2 hours

    shivering will be recorded in the recovery room for 2 hours

Secondary outcomes

  1. Visual Analogue Pain Score

    Time frame: 2 hours

    analgesics will be given if visual analogue score ≥ 4

  2. Complications

    Time frame: 2 hours

    percentage of patients with any complications will be recorded

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 4, 2017
Registry last updated
Jan 5, 2017

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.

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