Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT05731960

Evaluating the Effect of Intravenous Dexamethasone on the Duration of Spinal Anesthesia After Cesarean Delivery

Led by IWK Health Centre · Updated on 2024-07-08

192

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to determine the effects of intravenous (IV) dexamethasone on spinal anesthesia in healthy women having an elective Cesarean delivery (CD) at the IWK Health Centre. The main questions it aims to answer are: 1. What effect does IV dexamethasone have on the resolution of motor blockade in patients having spinal anesthesia for elective CDs? 2. What effect does IV dexamethasone have on the sensory recovery of spinal blockade, the total hydromorphone requirement in the first 24 h postoperatively, the incidence of pruritis perioperatively, and the incidence of nausea and vomiting? The spinal anesthesia technique will be standardized and will be administered as per routine care at IWK Health. Computer generation will randomize patients to either Group SD, who will receive IV dexamethasone, or group SM who will receive IV metoclopramide, an alternative anti-emetic, immediately after spinal anesthesia by the attending anesthesia provider. Each patient will receive ondansetron, a second anti- emetic as recommended for Enhanced Recovery After Surgery (ERAS) protocol. Participant sensation, pain, nausea, pruritus, and motor blockade will be assessed in recovery. The patient's sensation and Bromage score will be assessed every 15 minutes until sensation is reached at L3 and a Bromage score of 4 is achieved. The investigators will determine if there is a difference between groups regarding motor blockade, the length of time of spinal anesthesia, and side effects after CD.

CONDITIONS

Official 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-emergent Cesarean Delivery with planned spinal anesthesia
  • American Society of Anesthesia physical status class less than III
  • Age 18 years or older
  • Term pregnancy at 37 weeks or more
  • Singleton pregnancy
  • Moderate fluency in English
Not Eligible

You will not qualify if you...

  • Obesity with BMI 45 kg/m2 or higher
  • Height less than 5 feet
  • Significant obstetric or neonatal health issues such as severe maternal cardiac disease, preeclampsia, or fetal anomalies
  • Opioid tolerance or sensitivity
  • Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
  • Contraindications to neuraxial analgesia such as coagulopathy, infection, or neuropathy
  • Abnormal spinal anatomy including severe scoliosis, spina bifida, or spinal instrumentation
  • Use of chronic steroids
  • Physical or psychiatric conditions that impair cooperation

AI-Screening

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Trial Site Locations

Total: 1 location

1

IWK Health Centre

Halifax, Nova Scotia, Canada, B3K 6R8

Actively Recruiting

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Research Team

A

Allana Munro, MD FRCPC

CONTACT

K

Kwesi Kwofie, MD FRCPC

CONTACT

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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