Magnesium for Shivering in Epidural Lidocaine Deliveries (Mag-SHIELD)

• ClinicalTrials.gov Identifier: NCT03439358
• Recruitment Status: Suspended
• First Posted: February 20, 2018
• Last Update Posted: February 26, 2021
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): Anthony Chau, University of British Columbia

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Anesthesia	Drug: Magnesium Sulfate; Other: Normal Saline	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: June 11, 2018
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: September 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Magnesium sulfate; Magnesium sulfate (MgSO4) infusion will be commenced prior to epidural top-up.	Drug: Magnesium Sulfate; Bolus infusion: 100mL normal saline with 4g MgSO4 over 30 minutes Maintenance infusion: 25mL normal saline per hour with 1g MgSO4
Placebo Comparator: Normal saline; Normal saline infusion will be commenced prior to epidural top-up.	Other: Normal Saline; Bolus infusion: 100mL normal saline over 30 minutes Maintenance infusion: 25mL normal saline per hour

Outcome Measures

Primary Outcome Measures :

1. Incidence of intraoperative shivering [ Time Frame: Through completion of cesarean surgical procedure (maximum 2 hours) ]
   Incidence measured as shivering present or absent
2. Severity of intraoperative shivering [ Time Frame: Through completion of cesarean surgical procedure (maximum 2 hours) ]
   Severity measured subjectively by anesthesiologist and patient

Secondary Outcome Measures :

1. Incidence of hypothermia [ Time Frame: Through study completion (maximum 2.5 hours) ]
   Number of patients whose tympanic membrane temperature decreases below 36 degrees Celsius.
2. Incidence of hypotension [ Time Frame: Through study completion (maximum 2.5 hours) ]
   Number of patients who experience a greater than or equal to 20% reduction in systolic blood pressure.
3. Total vasopressor(s) dose [ Time Frame: Through study completion (maximum 2.5 hours) ]
4. Total utertonic(s) dose [ Time Frame: Through completion of cesarean surgical procedure (maximum 2 hours) ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Canada, British Columbia

BC Women's Hospital

Vancouver, British Columbia, Canada, V6H 3N1

Sponsors and Collaborators

University of British Columbia

Investigators

• Principal Investigator: Anton Chau, MD MMSc; University of British Columbia
• Study Chair: Anna West, BA MBBS; University of British Columbia
• Study Chair: Vit Gunka, MD; University of British Columbia
• Study Chair: Jonathan Collins, BA BM BCh MA; University of British Columbia
• Study Chair: Monica Brunner, MD; University of British Columbia
• Study Chair: Arianne Albert, PhD; Provincial Health Services Authority
• Study Chair: James D Taylor, BSc; Provincial Health Services Authority

More Information

• Responsible Party: Anthony Chau, Clinical Assistant Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT03439358
• Other Study ID Numbers: H17-02408
• First Posted: February 20, 2018
• Last Update Posted: February 26, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anthony Chau, University of British Columbia:

Epidural top-up; Shivering; Magnesium

Additional relevant MeSH terms:

Magnesium Sulfate; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Anti-Arrhythmia Agents; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Tocolytic Agents; Reproductive Control Agents