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Enrolling by invitation NCT07615595

Dexamethasone to Prevent Side Effects of Spinal Anesthesia in Cesarean Delivery

Phase IV Interventional Hypotension During Cesarean Delivery Postoperative Nausea and Vomiting (PONV) Pain, Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexamethasone, Placebo.
Who it may be relevant to
Registry conditions: Hypotension During Cesarean Delivery, Postoperative Nausea and Vomiting (PONV), Pain, Postoperative. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of the Effectiveness of Intravenous Dexamethasone in Preventing Adverse Effects of Spinal Anesthesia in Parturients Undergoing Cesarean Delivery

Overview

The goal of this clinical trial is to evaluate the effectiveness of intravenous dexamethasone in preventing adverse effects of spinal anesthesia and prolonging postoperative analgesia in parturients undergoing elective cesarean delivery. The main questions it aims to answer are: Does intravenous dexamethasone reduce the incidence of post-spinal hypotension? Does intravenous dexamethasone reduce the incidence of postoperative nausea and vomiting (PONV)? Does intravenous dexamethasone prolong the duration of postoperative analgesia? Researchers will compare intravenous dexamethasone (8 mg) to a placebo (0.9% saline) to see if dexamethasone effectively prevents post-spinal hypotension and PONV, and improves postoperative pain relief. Participants will: Receive an intravenous injection of either 8 mg dexamethasone or a placebo (2 mL 0.9% saline) prior to receiving spinal anesthesia. Have their blood pressure recorded frequently (every minute for the first 20 minutes, then every 5 minutes until the completion of surgery). Undergo sensory block assessment (via cold testing) and motor block evaluation (using the Bromage scale). Have maternal glycemia and neonatal safety monitored for potential steroid-related adverse effects.

Interventions

  • Drug Dexamethasone
    Intravenous administration of 8 mg dexamethasone immediately before the induction of spinal anesthesia.
  • Other Placebo
    Intravenous administration of 2 mL of 0.9% normal saline as a placebo immediately before the induction of spinal anesthesia.

Primary outcome measures

  • Incidence of Post-Spinal Hypotension [Time frame: From the induction of spinal anesthesia until the completion of surgery]
Secondary outcome measures (2)
  • Incidence of Postoperative Nausea and Vomiting (PONV) [Time frame: From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours)]
  • Duration of Postoperative Analgesia [Time frame: From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Singleton pregnancy
  • Gestational age ≥ 37 weeks
  • American Society of Anesthesiologists (ASA) physical status classification of II-III
  • Planned for elective cesarean delivery under spinal anesthesia

Exclusion criteria

  • Gestational diabetes mellitus or pre-existing (chronic) diabetes mellitus
  • Gestational hypertension or chronic hypertension
  • Body mass index (BMI) ≥ 35 kg/m²
  • Known allergy to dexamethasone
  • Current long-term corticosteroid therapy
  • Diagnosis of postpartum hemorrhage

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Vietnam · 1 center
  • University Medical Center Ho Chi Minh City (UMC) - Campus 2 — Ho Chi Minh City

Identifiers

NCT: NCT07615595 · 4667/UMP-BOARD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗