Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries: Effect on Postoperative Pain and Diaphragmatic Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Total opioids consumption.
研究概览
简要总结
Comparison between the effects of intrathecal morphine versus intrathecal dexmedetomidine on analgesia and respiratory function, in open heart surgery.
详细描述
Postoperative pulmonary dysfunction is a well-recognized complication of open-heart surgeries. About 25% of patients who don't present with any severe impaired cardiac function reported to have significant pulmonary dysfunction for at least one week after operation. Many mechanisms could be accused of this dysfunction as respiratory mechanics failure by diaphragmatic paresis or paralysis, pain and muscle guarding, lung atelectasis, drains discomfort, etc.
although pain is the major concern of patients, but sometimes it may not get the proper attention, pain in open heart surgery origins mainly from the surgical incision which is here a median sternotomy the most commonly used approach and the easiest access to the heart region, however median sternotomy may significantly impedes the pulmonary function by the resultant pain of this procedure and cause morbidity and mortality by itself
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, 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
- •Cardiac patient scheduled for elective open heart valve replacement surgery.
排除标准
- •• Patient refusal
- •Coagulation disorders
- •History of known allergy to the used drugs.
- •Combined procedures (e.gif combined with coronary artery bypass or aortic root surgeries).
- •If thoracotomy or min-sternotomy is planned for the surgery.
- •Re-do and emergency surgeries.
- •History of chronic chest diseases (COPD or IPF).
- •History of thoracotomy, pneumothorax, pneumomediastinum, phrenic nerve injury (as evident by the presence of paralysis of the ipsilateral hemidiaphragm when examined preoperatively).
- •Neuromuscular diseases.
- •Brain injuries.
研究组 & 干预措施
Intrathecal morphine group (Group M):
• Patients in this group will receive intrathecal morphine (0.5 mg diluted in I ml of normal saline) prior to induction of general anesthesia.
干预措施: Intrathecal morphine or dexmedetomidine (Drug)
Intrathecal dexmedetomidine group (Group D):
• Patients in this group will receive intrathecal dexmedetomidine (5 mcg diluted in 1 ml of normal saline) prior to induction of general anesthesia.
干预措施: Intrathecal morphine or dexmedetomidine (Drug)
结局指标
主要结局
Total opioids consumption.
时间窗: First 24 hour postoperatively
Pain would be assessed subjectively by the patient using the numerical scale from 0 to 10 by the and boluses of fentanyl 1 mic/kg would be given when requested by the patient, then the total fentanyl consumption during the first 24h post operative would be calculated.
次要结局
- Diaphragmatic function(First 24 hour postoperatively)
研究者
Sara Usama Mohammed Rabie
Principle investigator
Assiut University