Magnesium for Shivering in Epidural Lidocaine Deliveries (NCT03439358) | Clinical Trial Compass
SuspendedNot Applicable
Magnesium for Shivering in Epidural Lidocaine Deliveries
Stopped: Could not recruit patients
Canada90 participantsStarted 2018-06-11
Plain-language 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.
Who can participate
Age range
19 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Gestational age of ≥37 weeks
. Women who are ≥ 19 years old
. Women undergoing Cesarean delivery under lidocaine top-up via a preexisting epidural catheter inserted for labor analgesia
. American Society of Anesthesiologist (ASA) Physical Status class 1 or 2
Exclusion criteria
. Emergency Cesarean delivery with limited time for informed consent
. Women who have received MgSO4 prior to study enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of intraoperative shivering
Timeframe: Through completion of cesarean surgical procedure (maximum 2 hours)
2
Severity of intraoperative shivering
Timeframe: Through completion of cesarean surgical procedure (maximum 2 hours)
. Indication for alternative mode of anesthesia for Cesarean delivery (e.g., general anesthesia)
. 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)
. Active shivering at time of recruitment
. Inability to read and understand English for the purpose of informed consent
. 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)