RecruitingPhase 4NCT05731960

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

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


Sponsor

IWK Health Centre

Enrollment

192 participants

Start Date

Mar 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • Non-emergent Caesarean Delivery with planned spinal anesthesia
  • American Society of Anesthesia physical status class < III
  • Age ≥18 years
  • Term gestational age (≥37weeks)
  • Singleton pregnancy
  • Moderate English language fluency

Exclusion Criteria9

  • Obesity (BMI ≥ 45kg/m2)
  • Height < 5'0"
  • Patients with significant obstetric or neonatal co-morbidities (i.e., severe maternal cardiac disease, preeclampsia, fetal anomalies)
  • Opioid tolerance or sensitivity
  • Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
  • Contraindication to neuraxial analgesia (i.e., coagulopathy, infection, neuropathy)
  • Abnormal spinal anatomy (i.e., severe scoliosis, spina bifida, spinal instrumentation)
  • Use of chronic steroids
  • A physical or psychiatric condition which impairs cooperation

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Interventions

DRUGDexamethasone

10 mg IV dexamethasone provided immediately after spinal anesthesia

DRUGMetoclopramide

10 mg IV metoclopramide provided immediately after spinal anesthesia


Locations(1)

IWK Health Centre

Halifax, Nova Scotia, Canada

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NCT05731960


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