Prophylactic Efficacy and Safety of Intrathecal Dexamethasone, Atropine or Their Combination on Morphine Induced Post-operative Nausea and Vomiting on Patients Undergoing Caesarean Section With Spinal Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Incidence and severity of PONV
研究概览
简要总结
Pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. Low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain. Morphine has many complications like post-operative nausea and vomiting (PONV). the investigators will investigate the utility of intrathecal (IT) atropine and dexamethasone for prevention of morphine induced PONV as a primary outcome in parturient undergoing CS under spinal bupivacaine anesthesia plus morphine sulfate as an adjuvant.
详细描述
Pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. Low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain in many surgical areas including Caesarean delivery. Morphine has many complications namely pruritus, and post-operative nausea and vomiting (PONV). The other risk factors for the development of PONV include female gender, non-smoker status, general anesthesia with inhalational anesthetics and surgical factors (duration and type of surgery). The supplementation of morphine, however raises the occurrences of postoperative nausea and vomiting (PONV) in these patient To tackle this problem, the investigators have to use the combination therapy of antiemetics like a serotonin receptor antagonist of either intravenous (IV) ondansetron or granisetron with IV dexamethasone is administered after the administration of intrathecal morphine. Dopamine receptor antagonists e.g. droperidol and metoclopramide are commonly used, but they carry the risk of extrapyramidal symptoms.
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
- Single (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
- 是
入选标准
- •18-45 years old
- •Elective caesarean section under spinal anaesthesia.
排除标准
- •Patient refusal.
- •Contraindications to spinal anaesthesia as coagulopathy, infection at site of injection, hemodynamic instability and uncooperative patient.
- •Contraindications to administration of morphine as asthmatic patient and hypersensitivity and contraindications to any of the study drugs.
- •Adult-Emergency CS as there is no time for preparation and risk on fetus and mother for time consuming
研究组 & 干预措施
Dexamethasone group (D)
Patients will receive intrathecal hyperbaric bupivacaine 0.5% in a dose of 12.5 mg (2.5 ml) mixed with morphine in a dose of 200 µg (0.5 ml was withdrawn from a syringe containing 4 mg morphine sulfate diluted in 10 ml normal saline) [Total volume 4 ml], followed by intrathecal dexamethasone 4 mg (1ml).
干预措施: Atropine and Dexamethasone (Drug)
Atropine group (A)
Patients will receive intrathecal hyperbaric bupivacaine 12.5 mg (2.5 ml 0.5%) mixed with morphine 200 µg (0.5 ml) and atropine100 µg (0.5 ml was withdrawn from a syringe containing 2 mg atropine sulfate diluted in 10 ml normal saline) [Total volume 3.5 ml].
干预措施: Atropine and Dexamethasone (Drug)
Dexamethasone and Atropine group (DA)
Patients will receive intrathecal hyperbaric bupivacaine in a dose of 12.5 mg (2.5 ml) mixed with morphine 200 µg (0.5 ml) and atropine 100 µg (0.5 ml), followed by intrathecal injection of dexamethasone 4 mg (1 ml) [Total volume 4.5 ml] .
干预措施: Atropine and Dexamethasone (Drug)
结局指标
主要结局
Incidence and severity of PONV
时间窗: 24 hour
Incidence and severity of PONV by designing questionnaire and specific scale: 1. no nausea or vomiting 2. mild nausea and vomiting but no need to treatment 3. moderate nausea and vomiting that need treatment 4. severe form of nausea and vomiting and resistant to treatment
次要结局
- Antiemetic(24 hour)
- Post-operative pain profile(24 hour)
- Incidence of Side Effects(24 hour)
- Analgesia(24 hour)
研究者
Ahmed Shaban Abd Elbadea Khalifa
Anaesthesia and ICU Resident
Assiut University