Clincosm LogoSign in Get a demo

Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03008850
Collaborator
(none)
84
Enrollment
1
Location
2
Arms
18
Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group M

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

Drug: MgSo4
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.
Active Comparator: Group P

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

Drug: Placebo
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.

Outcome Measures

Primary Outcome Measures

  1. Shivering Score [2 hours]

    shivering will be recorded in the recovery room for 2 hours

Secondary Outcome Measures

  1. Visual Analogue Pain Score [2 hours]

    analgesics will be given if visual analogue score ≥ 4

  2. Complications [2 hours]

    percentage of patients with any complications will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age 18 to 35years.

  2. Undergo elective cesarean section under spinal anesthesia.

  3. ASA physical status I-II.

  4. Singleton pregnancy.

  5. At least 38 weeks gestation.

Exclusion Criteria:

  1. Women with history of cardiac, liver or kidney diseases.

  2. Women with allergy to amide local anesthetics or medication included in the study.

  3. Women with any neurological problem.

  4. Any contraindication of regional anesthesia.

  5. Failed or insatisfactory spinal block.

  6. Preoperative temperature more than 38⁰ C.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut university hospital Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Zain E. Hassan, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MOHAMED F. MOSTAFA, Lecturer of Anesthesia and Intensive Care, Assiut University
ClinicalTrials.gov Identifier:
NCT03008850
Other Study ID Numbers:
  • Shivering, MgSO4
First Posted:
Jan 4, 2017
Last Update Posted:
Jan 5, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by MOHAMED F. MOSTAFA, Lecturer of Anesthesia and Intensive Care, Assiut University
Shivering
Intrathecal
Magnesium Sulfate

Study Results

No Results Posted as of Jan 5, 2017