Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate

Cesarean Section; Shivering Clinical Trial

Official title:

Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008850
• Other study ID #: Shivering, MgSO4
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 27, 2016
• Last updated: January 3, 2017
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 38° C.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cesarean Section; Shivering

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shivering Score	shivering will be recorded in the recovery room for 2 hours	2 hours	Yes
Secondary	Visual Analogue Pain Score	analgesics will be given if visual analogue score = 4	2 hours	Yes
Secondary	Complications	percentage of patients with any complications will be recorded	2 hours	Yes