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临床试验/CTRI/2025/09/094940
CTRI/2025/09/094940尚未招募不适用

Comparison between intravenous Dexamethasone and intravenous Ondansetron for prevention of post spinal hypotension in patients undergoing elective lower segment caesarean section : A randomized controlled trial

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
285
试验地点
1
主要终点
To compare the incidence of post spinal hypotension between the study groups

研究概览

简要总结

Sub arachnoid block is the preferred anaesthesia for elective LSCS as it has better maternal and fetal outcome as compared to general anaesthesia. Most common side effect of spinal anaesthesia is post spinal hypotension with an incidence ranging from 50 to 80 % in patients undergoing LSCS. Post spinal hypotension can lead to serious maternal as well as fetal compromise due to reduced umbillical blood flow prior to delivery. Hence it is necessary to address this condition. Various pharmacological and non pharmacological agents have been tried to prevent and treat post spinal hypotension with varying degrees of effectiveness. Dexamethasone is relatively newer agent and it has shown promising outcome in preventing post spinal hypotension during LSCS. But its exact efficacy is yet to be proven . Ondansetron is an established drug for prevention of post spinal hypotension. Therefore our study aims to compare the efficacy of intravenous Dexamethasone and Intravenous Ondansetron for prevention of post spinal hypotension in elective LSCS as Dexamethasone is comparatively safer alternative for pregnant women with respect to Ondansetron.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women undergoing elective LSCS under Spinal anaesthesia
  • Singleton pregnancy
  • American society of anaesthesiologists physical status( ASA) 2
  • Gestational age more than 37 weeks.

排除标准

  • Gestational diabetes mellitus
  • Chronic diabetes mellitus
  • Hypertensive disorders of pregnancy
  • Cardiovascular insufficiency
  • BMI more than 40 kg/m2
  • Allergy to Dexamethasone or Ondansetron
  • Long QTsyndrome
  • Any contraindication to spinal anaesthesia
  • Patient refusal.

结局指标

主要结局

To compare the incidence of post spinal hypotension between the study groups

时间窗: • Systolic blood pressure will be recorded every 1 minutes till delivery

次要结局

  • 4. To compare the neonatal outcome (APGAR Score, umbilical artery Ph, blood sugar
  • 1. To compare the number of boluses of Phenylephrine
  • 2. To compare incidence of post delivery hypotension(Systolic blood pressure will be measured every 5 minutes after delivery till the end of the surgery)
  • 3. To compare the incidence of maternal bradycardia, nausea/vomiting, shivering
  • 5. Quality of recovery (QoR 15)(on the morning of surgery and 24 hours after surgery)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Shailendra Kumar

AIIMS New Delhi

研究点 (1)

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