NCT03439358

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 11, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

3.2 years

First QC Date

February 7, 2018

Last Update Submit

February 23, 2021

Conditions

Anesthesia

Keywords

Epidural top-upShiveringMagnesium

Outcome Measures

Primary Outcomes (2)

  • Incidence of intraoperative shivering

    Incidence measured as shivering present or absent

    Through completion of cesarean surgical procedure (maximum 2 hours)

  • Severity of intraoperative shivering

    Severity measured subjectively by anesthesiologist and patient

    Through completion of cesarean surgical procedure (maximum 2 hours)

Secondary Outcomes (4)

  • Incidence of hypothermia

    Through study completion (maximum 2.5 hours)

  • Incidence of hypotension

    Through study completion (maximum 2.5 hours)

  • Total vasopressor(s) dose

    Through study completion (maximum 2.5 hours)

  • Total utertonic(s) dose

    Through completion of cesarean surgical procedure (maximum 2 hours)

Study Arms (2)

Magnesium sulfate

EXPERIMENTAL

Magnesium sulfate (MgSO4) infusion will be commenced prior to epidural top-up.

Drug: Magnesium Sulfate

Normal saline

PLACEBO COMPARATOR

Normal saline infusion will be commenced prior to epidural top-up.

Other: Normal Saline

Interventions

Magnesium SulfateDRUG

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

Magnesium sulfate
Normal SalineOTHER

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

Normal saline

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Interventions

Magnesium SulfateSaline Solution

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Anton Chau, MD MMSc

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Anna West, BA MBBS

    University of British Columbia

    STUDY CHAIR

  • Vit Gunka, MD

    University of British Columbia

    STUDY CHAIR

  • Jonathan Collins, BA BM BCh MA

    University of British Columbia

    STUDY CHAIR

  • Monica Brunner, MD

    University of British Columbia

    STUDY CHAIR

  • Arianne Albert, PhD

    Provincial Health Services Authority British Columbia

    STUDY CHAIR

  • James D Taylor, BSc

    Provincial Health Services Authority British Columbia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 20, 2018

Study Start

June 11, 2018

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)