Efficacy of Ondansetron Versus Paracetamol for Prevention of Post-Operative Shivering
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of shivering
研究概览
简要总结
Shivering and vasoconstriction are thermoregulatory mechanisms that are required to increase core body temperature (BT) in patients with core hypothermia.
paracetamol is an antipyretic drug that has been in clinical use for a long time.
It can lower the BT of febrile and nonfebrile patients. A previous study demonstrated that orally administered paracetamol can suppress in a dose-dependent manner the increase in the BT of patients with acute ischemic stroke. However, few studies have evaluated the effects of paracetamol on postoperative shivering.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients between 18-40 years.
- •ASA physical status I and II
- •Both genders
- •Patients scheduled for elective mega-liposuction surgery under combined general epidural anesthesia
- •Exclusion criteria
- •Patients who refused to participate in the study,
- •ASA physical status more than II,
- •any contraindications to regional anesthesia,
- •surgical duration less than two hours or exceeding six hours,
- •giving history of any of the following; allergy to the study medications used, system impairment, alcohol abuse, any endocrine disease affecting body temperature such as thyroid disorders,
- •any psychiatric or neurological disorders, convulsions, patient receiving vasodilators or medications likely to alter thermoregulation,
- •Finally if their body temperature was recorded to surpass 37.5ºC or <36.5°C before enrolment.
排除标准
- 未提供
研究组 & 干预措施
saline group
干预措施: normal saline (Drug)
ondansetron group
干预措施: ondansetron (Drug)
paracetamol group
干预措施: paracetamol (Drug)
结局指标
主要结局
Incidence of shivering
时间窗: UP TO 1 HOURE
60 min postoperatively
次要结局
- The assessment the core temperatures(UP TO 24 HOURE)
- postoperative shivering scores(up to 2 hours)
研究者
Amr Samir Wahdan
Lecturer of Anesthesia, Pain management and Surgical ICU
Cairo University