Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
ID05731960

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Post-operative Follow-up

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

Loading map...

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

Similar Trials

Role of Intravenous Dexamethasone in Prolonging the Duration...

Spinal Anesthesia

Actively Recruiting

1 location

The Efficacy of Dexamethasone Versus Magnesium Sulphate as a...

Dexamethasone

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here