Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section: a Randomized Comparison of Metoclopramide or Ondansetron Alone or in the Combination With Dexamethasone.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section
研究概览
简要总结
Post-operative nausea and vomiting are the major complications after spinal anesthesia with intrathecal morphine, therefore antiemetic drugs should be administered for best satisfaction of anesthesia to prevent these complication.
Furthermore, administration of a combination of antiemetic drugs with different mechanisms of action appears reasonable and synergistic effect of drugs.
In conclusion, we study efficacy of antiemetic effect of single antiemetic drug compare with combination antiemetic drugs.
详细描述
In this study : a randomized, double-blind, placebo-controlled, clinical trial comparing single doses of Metoclopramide 10 mg and Ondansetron 8 mg alone and a combination of Dexamethasone 5 mg and Metoclopramide 10 mg or a combination of Dexamethasone 5 mg and Ondansetron 8 mg for prevention of PONV after spinal morphine for cesarean section.
Inclusion criteria
- Patient undergoes elective cesarean section age more than 18 years
- Patient accepted in spinal anesthesia technique
- ASA classification I-II
- Patient understand question and evaluation process
Exclusion criteria
- Hyperemesis gravidarum
- Patient with ongoing antiemetic drugs treatment
- Patient with history of drug allergy in Metoclopramide,Ondansetron and Dexamethasone
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •Pregnancy patients undergo Elective cesarean section age more than 18 years
- •Patient accept spinal anesthesia technique
- •ASA classification I-II
- •Patient understand question and evaluation process
- •Exclusion criteria:
- •Hyperemesis gravidarum
- •Patient ongoing treatment with antiemetic drugs
- •Allergy to Metoclopramide,Ondansetron and Dexamethasone
排除标准
- 未提供
研究组 & 干预措施
3
dexamethasone 5 mg and metoclopramide 10 mg
干预措施: dexamethasone (Drug)
4
dexamethasone 5 mg and ondansetron 8 mg IV
干预措施: dexamethasone 5 mg (Drug)
结局指标
主要结局
nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section
时间窗: 24 hrs post operatively
次要结局
- Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction(24 Hrs post operatively)