Clinical trial NCT03439358: Magnesium for Shivering in Epidural Lidocaine Deliveries
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Anesthesia
Keywords: Epidural top-up
Shivering
Magnesium
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 90
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Incidence of intraoperative shivering
timeFrame: Through completion of cesarean surgical procedure (maximum 2 hours)
measure: Severity of intraoperative shivering
timeFrame: Through completion of cesarean surgical procedure (maximum 2 hours)
Secondary outcomes:
measure: Incidence of hypothermia
timeFrame: Through study completion (maximum 2.5 hours)
measure: Incidence of hypotension
timeFrame: Through study completion (maximum 2.5 hours)
measure: Total vasopressor(s) dose
timeFrame: Through study completion (maximum 2.5 hours)
measure: Total utertonic(s) dose
timeFrame: Through completion of cesarean surgical procedure (maximum 2 hours)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Anton Chau, MD MMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Anna West, BA MBBS
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Vit Gunka, MD
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Jonathan Collins, BA BM BCh MA
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Monica Brunner, MD
role: STUDY_CHAIR
affiliation: Provincial Health Services Authority
name: Arianne Albert, PhD
role: STUDY_CHAIR
affiliation: Provincial Health Services Authority
name: James D Taylor, BSc
role: STUDY_CHAIR
References: