AnesthesiaMag-SHIELDNCT03439358
Magnesium for Shivering in Epidural Lidocaine Deliveries
A study testing Magnesium Sulfate and Normal Saline in people with Anesthesia, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Magnesium Sulfate and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jun 2018to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Magnesium Sulfate, Normal Saline
- Keywords
- Epidural top-up, Shivering, Magnesium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Bolus infusion: 100mL normal saline with 4g MgSO4 over 30 minutes Maintenance infusion: 25mL normal saline per hour with 1g MgSO4
Normal SalineOther
Bolus infusion: 100mL normal saline over 30 minutes Maintenance infusion: 25mL normal saline per hour
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate | Experimental | Magnesium sulfate (MgSO4) infusion will be commenced prior to epidural top-up. Receives: Drug: Magnesium Sulfate |
| Normal saline | Placebo comparator | Normal saline infusion will be commenced prior to epidural top-up. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative shivering
Incidence measured as shivering present or absent
Measured: Through completion of cesarean surgical procedure (maximum 2 hours)
Severity of intraoperative shivering
Severity measured subjectively by anesthesiologist and patient
Measured: Through completion of cesarean surgical procedure (maximum 2 hours)
Secondary outcomes (4)
Incidence of hypothermia
Number of patients whose tympanic membrane temperature decreases below 36 degrees Celsius.
Measured: Through study completion (maximum 2.5 hours)
Incidence of hypotension
Number of patients who experience a greater than or equal to 20% reduction in systolic blood pressure.
Measured: Through study completion (maximum 2.5 hours)
Total vasopressor(s) dose
Measured: Through study completion (maximum 2.5 hours)
Total utertonic(s) dose
Measured: Through completion of cesarean surgical procedure (maximum 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start11 Jun 2018
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: Could not recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Chau, University of British Columbia
- Investigators
- Anton Chau, MD MMSc, Principal investigator, University of British ColumbiaAnna West, BA MBBS, Study chair, University of British ColumbiaVit Gunka, MD, Study chair, University of British ColumbiaJonathan Collins, BA BM BCh MA, Study chair, University of British ColumbiaMonica Brunner, MD, Study chair, University of British ColumbiaArianne Albert, PhD, Study chair, Provincial Health Services Authority British ColumbiaJames D Taylor, BSc, Study chair, Provincial Health Services Authority British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439358
- Sponsor's protocol ID
- H17-02408
- Acronym
- Mag-SHIELD
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2018
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03439358
- Acronym / sponsor ID
- Mag-SHIELD / H17-02408
- Conditions
- Anesthesia
- Keywords
- Epidural top-up, Shivering, Magnesium
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Could not recruit patients
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate | Experimental | Drug: Magnesium SulfateMagnesium sulfate (MgSO4) infusion will be commenced prior to epidural top-up. |
| Normal saline | Placebo comparator | Other: Normal SalineNormal saline infusion will be commenced prior to epidural top-up. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateBolus infusion: 100mL normal saline with 4g MgSO4 over 30 minutes Maintenance infusion: 25mL normal saline per hour with 1g MgSO4 | Drug | Magnesium sulfate |
| Normal SalineBolus infusion: 100mL normal saline over 30 minutes Maintenance infusion: 25mL normal saline per hour | Other | Normal saline |
Primary outcome
Incidence of intraoperative shivering
Time frame: Through completion of cesarean surgical procedure (maximum 2 hours)
Incidence measured as shivering present or absent
Severity of intraoperative shivering
Time frame: Through completion of cesarean surgical procedure (maximum 2 hours)
Severity measured subjectively by anesthesiologist and patient
4 secondary outcomes
Incidence of hypothermia
Time frame: Through study completion (maximum 2.5 hours)
Incidence of hypotension
Time frame: Through study completion (maximum 2.5 hours)
Total vasopressor(s) dose
Time frame: Through study completion (maximum 2.5 hours)
Total utertonic(s) dose
Time frame: Through completion of cesarean surgical procedure (maximum 2 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Chau, MD MMSc principal investigator
University of British Columbia
Anna West, BA MBBS study chair
University of British Columbia
Vit Gunka, MD study chair
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate and Normal Saline in people with Anesthesia, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative shivering (time frame: Through completion of cesarean surgical procedure (maximum 2 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.