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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
Study 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).Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Resolution of motor blockade assessed by the Bromage motor blockade score
Secondary outcome measures
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%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
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
~2590
Find a Location
Who is running the clinical trial?
IWK Health CentreLead Sponsor
125 Previous Clinical Trials
100,281 Total Patients Enrolled
Allana Munro, MD FRCPCPrincipal InvestigatorIWK Health
Kwesi Kwofie, MD FRCPCPrincipal InvestigatorIWK Health
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Dexamethasone (Group SD) been given the green light by the FDA?
"Leveraging the Phase 4 trial that supports this medication's approval, our team at Power conservatively assessed Dexamethasone (Group SD) with a score of 3 in regards to safety."
Answered by AI
Are there any openings available in this clinical trial for potential participants?
"According to the clinicaltrials.gov record, this medical study is not searching for participants at present. Initially posted on February 1st 2023 and most recently updated on August 2nd 2023, there are 17 other trials actively recruiting despite its inactivity."
Answered by AI
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