Recruiting

Dexamethasone

Sponsor:

IWK Health Centre

Code:

NCT05731960

Conditions

Spinal Anesthesia

Dexamethasone

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Metoclopramide

Study Details

Brief 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.

Conditions

Spinal Anesthesia

Dexamethasone

Study ID

NCT05731960

Start date

Mar 6, 2023

Status verified date

Jul, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dexamethasone (Group SD)

10 mg IV dexamethasone x1

active comparator: Metoclopramide (Group SM)

10 mg IV metoclopramide x1

Interventions

Dexamethasone

10 mg IV dexamethasone provided immediately after spinal anesthesia

Metoclopramide

10 mg IV metoclopramide provided immediately after spinal anesthesia

Primary outcome measure

  • Resolution of motor blockade assessed by the Bromage motor blockade score [ Time Frame: Upon entrance to PACU until a Bromage score of 4 is achieved bilaterally ]

Central Contacts and Locations

Central contacts

Allana Munro, MD FRCPC

902-470-6627ammunro@dal.ca

Kwesi Kwofie, MD FRCPC

902-470-6627kwesi.kwofie@dal.ca

Locations

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

More Information

Sponsor

IWK Health Centre

Last update posted

Jul 8, 2024

Last verified

Jul, 2024

Keywords

  • spinal anesthesia
  • dexamethasone
  • motor block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2024-07-08.