Comparison Between Cyclizine and Dexamethasone for Prevention of Nausea and Vomiting After Intrathecal Morphine in Patients Undergoing Cesarean Section
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 主要终点
- Change in Post operative nausea and vomiting after intrathecal morphine by using PONV intensity scale.
研究概览
简要总结
Comparing between cyclizine and dexamethasone in preventing PONV after CS under spinal anesthesia with spinal opiate.
详细描述
Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery in patients. PONV is one of the most common causes of patient dissatisfaction after anesthesia, with reported incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. In addition, PONV is regularly rated in preoperative surveys, as the anesthesia outcome the patient would most like to avoid. While suture dehiscence, aspiration of gastric contents, esophageal rupture, and other serious complications associated with PONV are rare, nausea and vomiting is still an unpleasant and all-too-common postoperative morbidity that can delay patient discharge from the post-anesthesia care unit and increase unanticipated hospital admissions in outpatients.
There are many well-established risk factors for PONV which are classified in two classes:
A) Patient related risk factors:
- Female gender is consistently the strongest risk factor for PONV, female patient are three times more likely than men to suffer from PONV.
- For adult patient, age is a statistically, though not clinically, relevant risk factor, with the incidence of PONV decreasing as patients age. For pediatric patients, however, age increases the risk of post-operative vomiting (POV), such that children older than 3 years have been shown to have an increased risk of POV compared with children younger than 3 years.
- Obesity is a strong risk factor for PONV: patients with body mass index (BMI) more than 30 have the double risk of PONV.
- Non-smoking status roughly doubles the patient's risk of PONV. The specific mechanism underlying smoking's protective effect is unknown ,but one of the most commonly believed theories is that polycyclic aromatic hydrocarbons in cigarette smoke induce cytochrome P450 enzyme which increase the metabolism of emetogenic volatile anesthetics.
- History of gastrointestinal disease as gastritis, gastric ulcer or duodenal ulcer increases the risk for PONV.
- History of motion sickness, Meniere's disease or previous PONV indicates a general susceptibility to PONV.
B) Anesthesia related risk factors:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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
- •18 to 45 years old
- •Parturient
- •Full Term
排除标准
- •Women who has obstetric complications.
- •Women with evidence of foetal compromise.
- •Patients who have gastro-intestinal diseases.
- •Administration of anti-emetic drugs within 24 hours before operation.
- •Patients who have hyperemesis gravidarium
研究组 & 干预措施
Dexamethasone
干预措施: IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section (Drug)
Cyclizine
干预措施: IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section (Drug)
结局指标
主要结局
Change in Post operative nausea and vomiting after intrathecal morphine by using PONV intensity scale.
时间窗: Change in severity of nausea and vomiting 30 minutes , 3 hours, 6 hours after intervention
Nausea and vomiting were recorded as present or absent, All measurements and ratings were completed at the time when patients rated their PONV intensity. We also recorded factors known to be associated with the risk of developing PONV, including known risk factors for PONV.
次要结局
- Change in postoperative pain (assessed by VAS ).(Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours)
研究者
Mina Elia Azmy Habib
Principal Investigator
Assiut University