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IV Dexamethasone for Spinal Anesthesia
Phase 4
Recruiting
Led By Allana Munro, MD FRCPC
Research Sponsored by IWK Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operatively at time of pacu discharge
Awards & highlights
Summary
This trial will examine the effects of IV dexamethasone on spinal anesthesia outcomes in women undergoing Cesarean delivery. They'll measure motor blockade, time of spinal anesthesia, and side effects.
Who is the study for?
This trial is for healthy women over 18, with a single baby at term (≥37 weeks), planning a non-emergency Cesarean delivery using spinal anesthesia. They should speak moderate English and have an ASA physical status class < III. Excluded are those with contraindications to spinal analgesia, abnormal spine anatomy, significant health issues, height under 5'0", chronic steroid use, NSAID intolerance, opioid sensitivity or tolerance, and severe obesity (BMI ≥45kg/m2).
What is being tested?
The study tests if IV dexamethasone affects the duration of motor and sensory blockade from spinal anesthesia in elective Cesarean deliveries compared to IV metoclopramide. Women will be randomly assigned to receive either dexamethasone or metoclopramide after their anesthesia. Recovery assessments include sensation level checks every 15 minutes until specific recovery criteria are met.
What are the potential side effects?
Potential side effects may include nausea and vomiting despite anti-emetic drugs like ondansetron being used as part of the protocol. There's also a possibility of pruritus (itchiness) perioperatively due to the medications administered.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ retrieved at 24 hours following spinal anesthesia.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~retrieved at 24 hours following spinal anesthesia.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Resolution of motor blockade assessed by the Bromage motor blockade score
Secondary study objectives
Incidence of pruritis (itching)
Incidence of vomiting
Nausea intensity scores assessed by NRS
+3 moreSide effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Cerebrospinal fluid leak
2%
Deep Vein Thrombosis
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dexamethasone (Group SD)Experimental Treatment1 Intervention
10 mg IV dexamethasone x1
Group II: Metoclopramide (Group SM)Active Control1 Intervention
10 mg IV metoclopramide x1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2640
Find a Location
Who is running the clinical trial?
IWK Health CentreLead Sponsor
126 Previous Clinical Trials
102,390 Total Patients Enrolled
Allana Munro, MD FRCPCPrincipal InvestigatorIWK Health
Kwesi Kwofie, MD FRCPCPrincipal InvestigatorIWK Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have spinal or epidural pain relief due to a bleeding disorder, infection, or nerve disease.I am tolerant or sensitive to opioids.My BMI is 45 or higher.I am 18 years old or older.I am scheduled for a C-section with spinal anesthesia.I have a severe spine condition like scoliosis.I am on long-term steroid medication.I am shorter than 5 feet.
Research Study Groups:
This trial has the following groups:- Group 1: Dexamethasone (Group SD)
- Group 2: Metoclopramide (Group SM)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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