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临床试验/CTRI/2022/03/040772
CTRI/2022/03/040772尚未招募1/2 期

Comparison of the effect of intravenous and inrathecal dexamethasone on prevention of post op nausea and vomiting in patients posted for caesarean section

AIIMS JODHPUR1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年10月3日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
AIIMS JODHPUR
入组人数
90
试验地点
1
主要终点
The primary outcome is to find the efficacy of intravenous and intrathecal dexamethasone on preventing the PONV in pregnant patients undergoing caesarean section (CS) under spinal anaesthesia measured in terms of number of episodes of nausea and/or vomiting in 24 hours postoperatively.

研究概览

简要总结

.

**AIM:**To assess the effect of intravenous and intrathecal dexamethasone on the prevention of PONVinpatients posted for CS

OBJECTIVES:

Primary:

To find the efficacy of intravenous and intrathecal dexamethasone on preventing the PONV in pregnant patients undergoing cesarean section (CS) under spinal anaesthesia measured in terms of number of episodes of nausea and/or vomiting in 24 hours postoperatively.

Secondary:

1. Total antiemetic consumption in 24hrs

2.   Onset of sensory block(Block completion to grade 1 sensory block)

3.   Duration of analgesia defined as the time from onset of sensory block to first rescue analgesic(patient demand/VAS>3)

4.  Total analgesic consumption in 24 hrs

  1. Quality of analgesia (VAS)

6. To assess the adverse effects/complication, if any

  1. Patient satisfaction (Likert Scale)

The study involves 3 groups. The 1st group will be receiving intrathecal dexamethasone (1ml) and bupivacaine of 1.5 ml with intravenous normal saline of 1 ml

The 2nd group will be receiving intrathecal bupivacaine (1.5 ml) and normal saline (1ml) with intravenous dexamethasone (1ml)

The 3 rd control group will be receiving both normal saline in intravenous and intra thecal group along with 1.5 ml of intrathecal bupivacaine

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant patients undergoing emergency/elective Cesarian Section under spinal anaesthesia.

排除标准

  • 1.Refusal of informed consent 2.Hemodynamic instability 3.Patients having an allergic reaction to steroids 4.Fever or infection 5.Patient with an underlying medical condition with long term use of steroids 6.Patients having pregnancy-associated complications(hyperemesis gravidarum) 7.History of gastrointestinal disorders, motion disorders 8.Use of an antiemetic drug received before surgery.

结局指标

主要结局

The primary outcome is to find the efficacy of intravenous and intrathecal dexamethasone on preventing the PONV in pregnant patients undergoing caesarean section (CS) under spinal anaesthesia measured in terms of number of episodes of nausea and/or vomiting in 24 hours postoperatively.

时间窗: Episodes within 24 hrs

次要结局

  • Total antiemetic consumption(Onset of sensory block)

研究者

发起方
AIIMS JODHPUR
申办方类型
Research institution and hospital

研究点 (1)

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