Comparative Study Between the Efficacy of Intravenous Hydrocortisone and Intravenous Dexmedetomidine for Prevention of Postoperative Shivering After General Anaesthesia for Abdominal Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of participants with body respond to decrease in body temperature by shivering
研究概览
简要总结
The aim and purpose of this study is to compare the efficacy of intravenous hydrocortisone and intravenous dexmedetomidine for prevention and treatment of postoperative shivering after general anesthesia for abdominal surgeries.
详细描述
- . Type of Study: Randomized controlled clinical trial.
- Study Settings: Ain Shams University hospitals, Cairo, Egypt.
- Study Population: patients undergoing abdominal open surgeries with general anesthesia.
- Inclusion Criteria:
- ASA I or ASA II patients Scheduled for abdominal surgery under general anaesthesia.
- Age between18-65 years.
- Procedure duration ≤ 120 minutes.
- Exclusion Criteria:
- Patients with known neurologic and psychiatric illness.
- Uncontrolled diabetic patients.
- Patients on long term steroid therapy.
- Allergy to any of the drugs used in the study.
- Pregnancy and lactation.
- Hypo or hyperthyroidism.
- Sampling Method: Simple randomization
- Standard care Standard care for all patients undergoing this study will be done by senior staff expert members of Ain-Shams University Anesthesia department and will be monitored by supervisors.
- Study Procedures:
- Preoperative settings:
All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery.
• Intraoperative and postoperative settings:
Patients will be divided into two groups:
- Group A: (HYDROCORTISONE group): will receive 2mg/kg .
- Group B: (Dexmedetomidine group): will receive 1 µg/kg . On arrival to the operating room, routine monitors will be applied, including a blood pressure cuff, electrocardiogram, pulse oximeter, and capnogram. core temperature will be measured using temperature probe to determine baseline values. An intravenous ringer infusion will be started. Pre oxygenation will be done with 100% oxygen on 6L\m for 3 minutes. Anesthesia will be induced with propofol 2 mg/kg, fentanyl 2 mic\kg and atracurium 0.5 mg/kg. After endotracheal intubation, anesthesia will be maintained with 1.2-1.5% isoflurane. Mechanical ventilation will be adjusted to maintain end-tidal carbon dioxide tension at 30-35 mmHg Patients will be covered with surgical drapes. Supplemental doses of atracurium will be given every 20 minutes to maintain muscle relaxation during surgery.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any patient undergoing abdominal surgery ASAI or II.
排除标准
- •Patients with known neurologic and psychiatric illness.
- •Uncontrolled diabetic patients.
- •Patients on long term steroid therapy.
- •Allergy to any of the drugs used in the study.
- •Pregnancy and lactation.
- •Hypo or hyperthyroidism.
研究组 & 干预措施
Group A:(Hydrocortisone group)
• Group A: : received 2mg/kg.
干预措施: Hydrocortisone (Drug)
Group B: (Dexmedetomidine group)
• Group B: : received 1 µg/kg.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Number of participants with body respond to decrease in body temperature by shivering
时间窗: 30 minutes
In this study it was targeted to assess the efficacy of hydrocortisone and dexmedetomidine in reducing shivering that occur post operatively.
次要结局
未报告次要终点
研究者
maha sadek El Derh
assistant professor
Ain Shams University
