Comparison of Postoperative Hemodynamics After High Spinal Block With or Without Intrathecal Morphine in Cardiac Surgeries.
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 主要终点
- incidence of Vasoplegia
研究概览
简要总结
There is paucity of literature on the effects of intrathecal morphine on the postoperative hemodynamics in the cardiac-surgical patients.We planned this study to compare the post-operative hemodynamic effects (particularly the incidence of vasoplegia in the two study groups) and outcome of combined general anesthesia + high spinal block, with or without intrathecal morphine in patients undergoing cardiac-surgical procedures in our set up.
详细描述
Introduction Currently various strategies are being developed for fast tracking in cardiac anaesthesia that includes use of shorter acting opioids , combined thoracic epidural or high spinal anaesthesia with GA, awake cardiac surgery along with normothermic or mild hypothermic cardiopulmonary bypass (CPB) and off pump surgeries. The aim of fast tracking is early extubation, early mobilization, decreased length of ICU and overall hospital stay, not only to reduce costs and human resource utilisation but also to reduce the postoperative morbidity and mortality while enhancing the quality of health care.
Traditionally high dose opioid anaesthesia has been used to abolish this stress response, however, some studies have shown that this technique of anaesthesia only relatively minimizes the stress response and does not completely block it.
Regional anaesthesia in the form of thoracic epidural anaesthesia (TEA) alone (awake cardiac anaesthesia) or combined with general anaesthesia (GA) has been used in cardiac surgical patients. One of the useful alternatives to TEA would be high spinal anaesthesia as the risk of haematoma associated with this procedure is much less than the epidural in cardiac surgical patients. The use of spinal anaesthesia in cardiac patients, particularly patients with stenotic valvular lesions has been for long viewed with much apprehension, primarily due to the perceived risk of hypotension as a result of sympatholysis. However, various studies using high spinal up to T1 level have proved such apprehensions to be invalid in the setting of cardiac surgery where patients are monitored intensively with invasive monitors and the hypotension managed at the earliest with the use of small aliquots or continuous infusion of vasoactive agents such as phenylephrine, norepinephrine, epinephrine, mephentermine as per the requirements of underlying cardiac lesion.
Although thoracic epidural anaesthesia has been studied and practiced, there is paucity of literature on the effects of intrathecal morphine on the postoperative hemodynamics in the cardiac-surgical patients.Hence, the investigators planned this study to compare the post-operative hemodynamic effects and outcome of combined light general anesthesia + high spinal block, with or without intrathecal morphine in patients undergoing cardiac-surgical procedures in our set up.
Null Hypothesis Addition of intrathecal morphine in high spinal anesthesia does not affect postoperative hemodynamics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients with valvular heart disease and coronary artery disease of New York Heart Association class II-III aged 18 to 60 years undergoing elective cardiac surgery (Valve replacement/CABG).
排除标准
- •• All the standard contraindications for spinal anaesthesia which includes local site infection, spinal deformity, coagulopathy (platelet count<80,000, INR>1.5) patients on anticoagulant medication continued upto the day of the surgery as per the third edition of the American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy)
- •Redo surgery/emergency surgeries.
- •Patients having co-morbidities such as obesity (BMI more than 30), COPD, asthma, that are likely to require prolonged post operative mechanical ventilation.
- •Total surgery time > 6 hours.
- •History of opioid drug abuse or patients on opioids for treatment of chronic pain.
- •Known or anticipated difficult airway
研究组 & 干预措施
Bupivacaine
Intrathecal 8 ml single dose of 0.5% heavy Bupivacaine (Anawin heavy 0.5%).
干预措施: Bupivacaine (Drug)
Bupivacaine + Morphine
Intrathecal 8 ml single dose of 0.5% heavy Bupivacaine (Anawin heavy 0.5%) and 250 microgram of preservative free Morphine (VERMOR).
干预措施: Bupivacaine + Morphine (Drug)
结局指标
主要结局
incidence of Vasoplegia
时间窗: within 48 hours in post-operative period
Vasoplegia (defined by MAP \< 60mmHg with cardiac index \> 2.2L/min/m2 or requirement of vasopressors to maintain the MAP \> 60 mmHg in presence of cardiac index \> 2.2L/min/m2)
次要结局
- Mechanical ventilation duration.(post-operative 48 hours)
- Requirement of postoperative analgesia based on VAS(upto 48 hours of postoperative period)
- Spirometry performance(Upto 48 postoperative hours.)
- incidence of awareness under anesthesia(within 48 postoperative hours.)
- Time to extubation(within 48 hours in post-operative period)
研究者
IMRAN HUSSAIN BHAT
Post operative hemodynamic investigator
Post Graduate Institute of Medical Education and Research, Chandigarh