Role of Prophylactic Mirtazapine and Different Doses of Intrathecal Morphine in Preventing Nausea and Vomiting After Cesarean Section: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting
研究概览
简要总结
The aim of this work was to evaluate the role of prophylactic mirtazapine and different doses of intrathecal morphine in preventing nausea and vomiting.
详细描述
It is common practice to provide intrathecal morphine to alleviate postoperative pain because of its powerful and long-lasting analgesic effects. Mirtazapine is a noradrenergic and specific serotonergic antidepressant. It is anxiolytic by its antagonist of the 5HT2 receptor and is strongly sleep-inducing. Its antagonist at 5-hydroxytryptamine subtype 3 (5-HT3) receptor may help to prevent 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 years.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Scheduled for caesarean section under spinal anesthesia
排除标准
- •Known hypersensitivity to mirtazapine.
- •Gastrointestinal illness.
- •Diabetes mellitus.
- •Use of opioids or any medication with known antiemetic properties within 48 hours before surgery.
- •Mental disorders.
- •Spinal anesthesia contraindications.
- •Taking antidepressants or antipsychotic medications.
研究组 & 干预措施
Groups I
Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5% along with 0.2 mg of morphine.
干预措施: Mirtazapine + Bupivacaine + Morphine (Drug)
Groups II
Patients received 30mg of oral mirtazapine one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.
干预措施: Mirtazapine + Bupivacaine + Morphine (Drug)
Groups III
Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.2 mg of morphine.
干预措施: Placebo + Bupivacaine + Morphine (Drug)
Groups IV
Patients received a placebo one hour before surgery plus 10 mg of bupivacaine 0.5%, along with 0.1 mg of morphine.
干预措施: Placebo+ Bupivacaine + Morphine (Drug)
结局指标
主要结局
Incidence of postoperative nausea and vomiting
时间窗: 24 hours postoperatively
Incidence of postoperative nausea and vomiting was recorded at 3, 6, 12, 18, 24 hours postoperatively.
次要结局
- Degree of pain(24 hours postoperatively)
- Time to first rescue analgesia(24 hours postoperatively)
- Total pethidine consumption(24 hours postoperatively)
- Incidence of adverse events(24 hours postoperatively)
研究者
Basma Mohamed Ghoniem
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelshiekh University, Kafrelshiekh, Egypt
Kafrelsheikh University