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

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University of British Columbia

Status

Suspended

Conditions

Anesthesia

Treatments

Other: Normal Saline
Drug: Magnesium Sulfate

Study type

Interventional

Funder types

Other

Identifiers

NCT03439358
H17-02408

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

Female

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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
  • 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)
  • History of previous postpartum hemorrhage

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 2 patient groups, including a placebo group

Magnesium sulfate
Experimental group
Description:
Magnesium sulfate (MgSO4) infusion will be commenced prior to epidural top-up.
Treatment:
Drug: Magnesium Sulfate
Normal saline
Placebo Comparator group
Description:
Normal saline infusion will be commenced prior to epidural top-up.
Treatment:
Other: Normal Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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