Actively Recruiting
A Randomized Controlled Trial Evaluating the Effect of Intravenous Dexamethasone on the Duration of Spinal Anesthesia as Part of a Multimodal Antiemetic Strategy for Enhanced Recovery After Cesarean Delivery
Led by IWK Health Centre · Updated on 2024-07-08
192
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of intravenous (IV) dexamethasone on spinal anesthesia in healthy women undergoing elective Cesarean delivery (CD). This randomized, double-blind, controlled trial aims to understand how IV dexamethasone influences the duration of motor and sensory blockade from spinal anesthesia, as well as its impact on pain, nausea, vomiting, and itching after surgery. The study compares dexamethasone to metoclopramide, another anti-nausea medication, within a multimodal antiemetic strategy as part of Enhanced Recovery After Surgery (ERAS) protocols. Participants receive a standardized spinal anesthesia with bupivacaine, fentanyl, and morphine. They are randomly assigned to receive either 10 mg of IV dexamethasone or 10 mg of IV metoclopramide immediately after spinal anesthesia. All participants also receive ondansetron as a second antiemetic. Additional anti-nausea medications may be given if needed. The study monitors motor and sensory block recovery times closely using specific assessments like the Bromage score and sensation testing at regular intervals. During the study, participants are assessed for pain, nausea, itching, and motor function recovery in the recovery room at scheduled times until full recovery of motor function is confirmed. Pain and nausea scores are recorded hourly until full motor function returns. Opioid use is tracked for 24 hours after surgery, along with any episodes of vomiting or itching. The main outcome is the time until complete resolution of motor block. The study plans to include 116 participants and is conducted with careful data collection and statistical analysis to compare the two treatment groups.
CONDITIONS
Brief Title
Evaluating the Effect of Intravenous Dexamethasone on the Duration of Spinal Anesthesia After Cesarean Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-emergency Cesarean Delivery with planned spinal anesthesia
- American Society of Anesthesia physical status class less than III
- Age 18 years or older
- Term pregnancy (37 weeks or more)
- Singleton pregnancy
- Moderate English language fluency
You will not qualify if you...
- Obesity with BMI 45 kg/m2 or higher
- Height less than 5 feet 0 inches
- Significant obstetric or neonatal health problems such as severe maternal heart disease, preeclampsia, or fetal abnormalities
- Opioid tolerance or sensitivity
- Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
- Contraindications to spinal or epidural anesthesia such as coagulopathy, infection, or neuropathy
- Abnormal spinal anatomy including severe scoliosis, spina bifida, or spinal surgery
- Use of chronic steroids
- Physical or psychiatric conditions that impair cooperation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (day of Cesarean Delivery)
Participants receive spinal anesthesia for Cesarean Delivery and are randomly assigned to receive either an intravenous dose of dexamethasone or metoclopramide immediately after spinal anesthesia as part of a multimodal antiemetic strategy.
1 visit (in-person on day of surgery)
Duration - Up to several hours post-surgery until full motor blockade resolution
Participants are monitored in the post-anesthesia care unit (PACU) where motor blockade and sensory recovery are assessed regularly until full recovery. Pain, nausea, opioid use, and incidence of itching and vomiting are also evaluated during this time.
Multiple assessments every 15 minutes to every hour during PACU stay
Trial Site Locations
Total: 1 location
1
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
Research Team
A
Allana Munro, MD FRCPC
K
Kwesi Kwofie, MD FRCPC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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