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临床试验/NCT07615595
NCT07615595Enrolling By Invitation4 期

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

University Medical Center Ho Chi Minh City (UMC)1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
4 期
状态
Enrolling By Invitation
发起方
入组人数
176
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

发起方
University Medical Center Ho Chi Minh City (UMC)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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