Dexamethasone to Prevent Side Effects of Spinal Anesthesia in Cesarean Delivery

NCT07615595 | Enrolling By Invitation Phase 4

• 1 other identifier: 4667/UMP-BOARD
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypotension During Cesarean Delivery; Postoperative Nausea and Vomiting (PONV); Pain, Postoperative

Keywords

Dexamethasone; Prophylaxis; Elective Cesarean Delivery; Spinal-induced Hypotension; Postoperative Analgesia; Parturients

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-Spinal Hypotension

  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

  From the induction of spinal anesthesia until the completion of surgery

Secondary Outcomes (2)

• Incidence of Postoperative Nausea and Vomiting (PONV)

  From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours)

• Duration of Postoperative Analgesia

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

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Dexamethasone DRUG

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

Dexamethasone

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, placebo-controlled, single-blind, parallel-group clinical trial

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 29, 2026

Record last verified: 2025-11

Locations

VN (1)