Magnesium for Shivering in Epidural Lidocaine Deliveries

Not Applicable

Suspended

• Conditions: Anesthesia
• Interventions: Other: Normal Saline; Drug: Magnesium Sulfate

• Registration Number: NCT03439358
• Lead Sponsor: University of British Columbia

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.

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 Timeline

• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-20
• Study Start: 2018-06-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-26
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal Saline	Normal saline infusion will be commenced prior to epidural top-up.
Magnesium sulfate	Magnesium Sulfate	Magnesium sulfate (MgSO4) infusion will be commenced prior to epidural top-up.

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative shivering	Through completion of cesarean surgical procedure (maximum 2 hours)	Incidence measured as shivering present or absent
Severity of intraoperative shivering	Through completion of cesarean surgical procedure (maximum 2 hours)	Severity measured subjectively by anesthesiologist and patient

Secondary Outcome Measures

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

Trial Locations

Locations (1)

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada