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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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 weeks
Treatment ~ Varies
Follow Up ~retrieved at 24 hours following spinal anesthesia.
This trial's timeline: 3 weeks for screening, Varies for treatment, and retrieved at 24 hours following spinal anesthesia. for reporting.

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 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Awards & Highlights

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.

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
~2650

Find a Location

Who is running the clinical trial?

IWK Health CentreLead Sponsor
127 Previous Clinical Trials
110,906 Total Patients Enrolled
Allana Munro, MD FRCPCPrincipal InvestigatorIWK Health
Kwesi Kwofie, MD FRCPCPrincipal InvestigatorIWK Health

Media Library

Dexamethasone (Group SD) Clinical Trial Eligibility Overview. Trial Name: NCT05731960 — Phase 4
Spinal Anesthesia Research Study Groups: Dexamethasone (Group SD), Metoclopramide (Group SM)
Spinal Anesthesia Clinical Trial 2023: Dexamethasone (Group SD) Highlights & Side Effects. Trial Name: NCT05731960 — Phase 4
Dexamethasone (Group SD) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05731960 — Phase 4
~32 spots leftby Apr 2025
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