Comparison Between Intravenous Ondanosteron and Metclopromide Versus Ondanesteron and Dexamethasone Effects on the Prevention of Postoperative Nausea and Vomiting in Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- incidence of PONV
研究概览
简要总结
The goal of this clinical trial is to prevent intraoperative nausea and vomiting (IONV) and postoperative nausea and vomiting (PONV) through comparing the efficacy of combination ondanosteron plus metclopromide versus ondanesteron plus dexamethasonein in cesarean section . The main objective is to compare the incidence of PONV between the two groups in the first 24 hours.
Patients will be randamized allocated into two groups: Group D (Ondanesterone plus dexamethasone) or Group M (ondanesterone plus metoclopramide) .
详细描述
Introduction Cesarean section considered one of the most surgical interventions worldwide about 7%. About 80% of pregnant women suffer from Intra and postoperative nausea and vomiting (IONV and PONV) during cesarean delivery under spinal anesthesia.
IONV and PONV decrease patients' satisfaction, increase hospital stay and can lead to wound dehiscence, bleeding, water and electrolyte abnormalities, and rehospitalization. Majority of patients prefer to experience postoperative pain rather than nausea and vomiting.
Many causes may trigger IONV and PONV and most of them are preventable. Causes of IONV may be classified into anesthetic and surgical factors. Anesthetic factors such as hypotension due to spinal anesthesia and use of some drugs like utertonics, antibiotics and opioids. Surgical factors as visceral stimulation and uterine exteriorization. PONV is mainly triggered by the emetogenic effects of opioids and severe pain.
The National Institute for Health and Care Excellence (NICE) guidelines and Enhanced Recovery after Cesarean delivery (ERAC) protocols recommend prophylactic antiemetic therapy.
Ondanesteron (5HT3 receptor antagonists) alone or with combination considered the gold standard for prophylaxis of intra and post operative nausea and vomiting.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA II and III pregnant patients scheduled for elective C.S under spinal anesthesia
- •Age 18-45 years
- •Fasting before the procedure for 8 hours from solid food intake and 2 hours from water intake
排除标准
- •Patients with ASA physical status > III.
- •History of motion sickness and extrapyramidal disease.
- •History of allergy to any of involved drugs in the study.
- •Patients developed nausea and vomiting and/or received antiemetic drugs within 24 hours prior to surgery.
- •History of hyperemesis gravidarum.
- •History of peptic ulcer disease.
研究组 & 干预措施
Group D (Ondanesterone plus dexamethasone)
patients allocated in this group will receive 4mg Ondanesterone plus 8 mg dexamethasone slowly intravenous 15 minutes before spinal anesthesia.
干预措施: Ondanesterone plus dexamethasone combination (Drug)
Group M (ondanesterone plus metoclopramide)
patients allocated in this group will receive 4mg Ondanesterone plus 10 mg metoclopramide slowly intravenous 15 minutes before spinal anesthesia.
干预措施: ondanesterone plus metoclopramide combination (Drug)
结局指标
主要结局
incidence of PONV
时间窗: The first 24 hours postoperative
Comparing the incidence of PONV between the two groups in the first 24 hours between the two groups
次要结局
- Incidence of IONV(During the surgery)
- Intraoperative non invasive blood pressure(every 5 minutes for the first 20 minutes then every 10 minutes (with a maximum of 60 minutes)during the surgery)
- Rescue antiemetic(Intraoperaotive till 24 hours postoperative)
- Total antiemetic dose(The first 24 hours postoperative)
研究者
Aiman Al-Touny
Lecturer of Anesthesia and Intensive Care
Suez Canal University