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Enrolling by Invitation

NCT Number: NCT07615595

Dexamethasone to Prevent Side Effects of Spinal Anesthesia in Cesarean Delivery

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.

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Key information

Conditions

Hypotension During Cesarean Delivery Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Nausea and Vomiting (PONV) Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Ho Chi Minh City (UMC) - Campus 2

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Intravenous administration of 8 mg dexamethasone immediately before the induction of spinal anesthesia.

Placebo

Other

Intravenous administration of 2 mL of 0.9% normal saline as a placebo immediately before the induction of spinal anesthesia.

Primary outcomes

  1. Incidence of Post-Spinal Hypotension

    Time frame: From the induction of spinal anesthesia until the completion of surgery

    The number of participants experiencing at least one episode of post-spinal hypotension. Hypotension is defined as a decrease in systolic blood pressure of 20% or more from the baseline value. Baseline blood pressure is defined as the mean value of three consecutive measurements taken 2 minutes apart, with a variation of less than 10%. Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate are recorded every minute for the first 20 minutes after spinal anesthesia, and then every 5 minutes until the completion of surgery and transfer to the post-anesthesia care unit

Secondary outcomes

  1. 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)

    The number of participants experiencing nausea, vomiting, or retching, or requiring rescue antiemetic treatment. Rescue treatment is administered as intravenous ondansetron 4 mg or intravenous metoclopramide 10 mg.

  2. Duration of Postoperative Analgesia

    Time frame: From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)

    The time elapsed from the administration of spinal anesthesia to the patient's first request for systemic rescue analgesic medication. Rescue analgesia is administered when the patient complains of pain and records a Visual Analog Scale (VAS) score greater than 4 (on a scale of 0 to 10).

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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