Magnesium for Shivering in Epidural Lidocaine Deliveries

University of British Columbia90 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Anesthesia

Interventions

Magnesium SulfateDRUG

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

Normal SalineOTHER

Bolus infusion: 100mL normal saline over 30 minutes Maintenance infusion: 25mL normal saline per hour

Eligibility

Sex: FEMALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

BC Women's Hospital

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Incidence of intraoperative shivering

Incidence measured as shivering present or absent

Time frame: Through completion of cesarean surgical procedure (maximum 2 hours)

Severity of intraoperative shivering

Severity measured subjectively by anesthesiologist and patient

Time frame: Through completion of cesarean surgical procedure (maximum 2 hours)

Secondary Outcomes

Incidence of hypothermia

Number of patients whose tympanic membrane temperature decreases below 36 degrees Celsius.

Time frame: Through study completion (maximum 2.5 hours)

Incidence of hypotension

Number of patients who experience a greater than or equal to 20% reduction in systolic blood pressure.

Time frame: Through study completion (maximum 2.5 hours)

Total vasopressor(s) dose

Time frame: Through study completion (maximum 2.5 hours)

Total utertonic(s) dose

Time frame: Through completion of cesarean surgical procedure (maximum 2 hours)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.