<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03008850</url>
  </required_header>
  <id_info>
    <org_study_id>Shivering, MgSO4</org_study_id>
    <nct_id>NCT03008850</nct_id>
  </id_info>
  <brief_title>Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate</brief_title>
  <official_title>Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Shivering is a common post-anesthetic complication occurring in up to 65% of patients&#xD;
      undergoing spinal or epidural anesthesia. Shivering may interfere with electrocardiogram,&#xD;
      blood pressure and oxygen saturation monitoring. In addition, shivering increases oxygen&#xD;
      consumption, carbon dioxide production and metabolic rate by up to 400%. Thus, it may result&#xD;
      in problems in patients with low cardiac and pulmonary reserves. Preventing shivering could&#xD;
      therefore result in better postoperative outcomes or reduce the incidence of post-surgical&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Magnesium sulfate (MgSO4) has anti-shivering effects. Moreover, it has potential&#xD;
      neuroprotective effects and may enhance neuroprotection against the effects of hypothermia.&#xD;
      Intrathecal MgSO4 administration provides effective perioperative analgesia and can prolong&#xD;
      the period of anesthesia and sensory blockade without any additional side-effects. However,&#xD;
      most of the research on the role of MgSO4 in the prevention of shivering has focused on&#xD;
      intravenous infusion of this drug. Few clinical trials have examined the effect of adding&#xD;
      intrathecal MgSO4 to anesthetic agents such as bupivacaine to suppress anesthesia-related&#xD;
      shivering in patients. Similar to infusion studies, we hypothesized that the addition of&#xD;
      intrathecal injection of MgSO4 to bupivacaine would improve perioperative shivering in female&#xD;
      patients undergoing elective caesarean section. Few previous studies evaluated neuroaxial&#xD;
      anti-shivering effects of intrathecal magnesium and none evaluated the anti-shivering effect&#xD;
      of intrathecal MgSO4. Therefore, we elected to use the lowest dosage (25 mg MgSO4) that was&#xD;
      formerly utilized for investigation of analgesic effects.&#xD;
&#xD;
      Magnesium sulphate is an intracellular cation with various physiologic functions such as&#xD;
      enzyme activation, nerve signal conduction, protein synthesis and vasomotor tonicity&#xD;
      regulation. Magnesium sulphate has been used in various clinical situations including&#xD;
      preeclampsia, tocolysis, arrhythmias, myocardial ischemia, bronchial asthma and postoperative&#xD;
      shivering.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Shivering Score</measure>
    <time_frame>2 hours</time_frame>
    <description>shivering will be recorded in the recovery room for 2 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Pain Score</measure>
    <time_frame>2 hours</time_frame>
    <description>analgesics will be given if visual analogue score ≥ 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>2 hours</time_frame>
    <description>percentage of patients with any complications will be recorded</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Cesarean Section; Shivering</condition>
  <arm_group>
    <arm_group_label>Group M</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group P</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MgSo4</intervention_name>
    <description>Patients will be randomly allocated to one of two groups:&#xD;
Group (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally.&#xD;
Group(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally.</description>
    <arm_group_label>Group M</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Patients will be randomly allocated to one of two groups:&#xD;
Group (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally.&#xD;
Group(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally.</description>
    <arm_group_label>Group P</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 to 35years.&#xD;
&#xD;
          2. Undergo elective cesarean section under spinal anesthesia.&#xD;
&#xD;
          3. ASA physical status I-II.&#xD;
&#xD;
          4. Singleton pregnancy.&#xD;
&#xD;
          5. At least 38 weeks gestation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women with history of cardiac, liver or kidney diseases.&#xD;
&#xD;
          2. Women with allergy to amide local anesthetics or medication included in the study.&#xD;
&#xD;
          3. Women with any neurological problem.&#xD;
&#xD;
          4. Any contraindication of regional anesthesia.&#xD;
&#xD;
          5. Failed or insatisfactory spinal block.&#xD;
&#xD;
          6. Preoperative temperature more than 38⁰ C.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zain E. Hassan, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut university hospital</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>MOHAMED F. MOSTAFA</investigator_full_name>
    <investigator_title>Lecturer of Anesthesia and Intensive Care</investigator_title>
  </responsible_party>
  <keyword>Shivering</keyword>
  <keyword>Intrathecal</keyword>
  <keyword>Magnesium Sulfate</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03008850
org study id: Shivering, MgSO4
nct id: NCT03008850
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Shivering Score
time frame: 2 hours
description: shivering will be recorded in the recovery room for 2 hours
measure: Visual Analogue Pain Score
time frame: 2 hours
description: analgesics will be given if visual analogue score ≥ 4
measure: Complications
time frame: 2 hours
description: percentage of patients with any complications will be recorded
arm group label: Group M
arm group type: Active Comparator
description: 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally
arm group label: Group P
arm group type: Active Comparator
description: 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally
intervention type: Drug
intervention name: MgSo4
description: 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.
arm group label: Group M
intervention type: Drug
intervention name: Placebo
description: 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.
arm group label: Group P
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Zain E. Hassan, MD
role: Study Chair
affiliation: Assiut University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: MOHAMED F. MOSTAFA
investigator title: Lecturer of Anesthesia and Intensive Care
sharing ipd: Undecided