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

NCT05731960 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2024-07-08

No results posted yet for this study

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

Interventions

DRUG

Dexamethasone

10 mg IV dexamethasone provided immediately after spinal anesthesia

DRUG

Metoclopramide

10 mg IV metoclopramide provided immediately after spinal anesthesia

Sponsors & Collaborators

  • IWK Health Centre

    lead OTHER

Principal Investigators

  • Allana Munro, MD FRCPC · IWK Health

  • Kwesi Kwofie, MD FRCPC · IWK Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2025-04-30
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05731960 on ClinicalTrials.gov