Magnesium for Shivering in Epidural Lidocaine Deliveries

Anesthesia Clinical Trial

— Mag-SHIELD  

Official title:

Intravenous Magnesium Sulfate for the Prevention of Intraoperative Shivering in Parturients Undergoing Cesarean Delivery Under Lidocaine Top-up Via a Pre-existing Epidural Catheter Inserted for Labor Analgesia - A Randomized Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03439358
• Other study ID #: H17-02408
• Status: Suspended
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: September 2021

Study information

• Verified date: February 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Magnesium has been shown to decrease the shivering experienced from neuraxial anesthesia. This study aims to investigate whether magnesium decreases the shivering experienced in parturients undergoing labor epidural anesthesia for Cesarean delivery.

Description:

Women who have epidurals in place and go on to require a Cesarean delivery typically have their epidurals 'topped-up' with a fast onset local anesthetic to ensure the lower body is fully numb for surgery. This is called an epidural 'top-up'. However, a side effect of epidural top-ups is shivering, which is uncomfortable for the mother and interferes with patient monitoring. Magnesium administration has been shown to decrease shivering in the non-pregnant population. Therefore, in this study the investigators aim to determine if magnesium given prior to an epidural top-up decreases the incidence and severity of shivering in the pregnant population.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 90
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Gestational age of =37 weeks

2. Women who are = 19 years old

3. Women undergoing Cesarean delivery under lidocaine top-up via a preexisting epidural catheter inserted for labor analgesia

4. American Society of Anesthesiologist (ASA) Physical Status class 1 or 2

Exclusion Criteria:

1. Emergency Cesarean delivery with limited time for informed consent

2. Women who have received MgSO4 prior to study enrollment

3. Indication for alternative mode of anesthesia for Cesarean delivery (e.g., general anesthesia)

4. Medical conditions or medications that could lead to tremor or shivering. (e.g., movement disorder, untreated thyroid disease) or mask tremor or shivering (e.g., beta-blocker, benzodiazepine, anticonvulsants)

5. Active shivering at time of recruitment

6. Inability to read and understand English for the purpose of informed consent

7. Contraindications to receiving MgSO4 (hypersensitivity reactions, respiratory rate <16breaths/min, absent reflexes, urine output <100 mL during the previous 4 hours, renal failure, or hypocalcemia)

8. History of previous postpartum hemorrhage

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Magnesium Sulfate
Bolus infusion: 100mL normal saline with 4g MgSO4 over 30 minutes Maintenance infusion: 25mL normal saline per hour with 1g MgSO4

Other:
• Normal Saline
Bolus infusion: 100mL normal saline over 30 minutes Maintenance infusion: 25mL normal saline per hour

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intraoperative shivering	Incidence measured as shivering present or absent	Through completion of cesarean surgical procedure (maximum 2 hours)
Primary	Severity of intraoperative shivering	Severity measured subjectively by anesthesiologist and patient	Through completion of cesarean surgical procedure (maximum 2 hours)
Secondary	Incidence of hypothermia	Number of patients whose tympanic membrane temperature decreases below 36 degrees Celsius.	Through study completion (maximum 2.5 hours)
Secondary	Incidence of hypotension	Number of patients who experience a greater than or equal to 20% reduction in systolic blood pressure.	Through study completion (maximum 2.5 hours)
Secondary	Total vasopressor(s) dose		Through study completion (maximum 2.5 hours)
Secondary	Total utertonic(s) dose		Through completion of cesarean surgical procedure (maximum 2 hours)