Effect of Intrathecal Dexamethasone on Intra-operative Hemodynamic in Elderly Patients Undergoing Urologic Endoscopic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Total amount of fluids
研究概览
简要总结
Correction of Post-spinal anesthesia hypotension by fluids pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance Many advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering.
In this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.
详细描述
Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgery. Spinal anesthesia avoids the risks of general anesthesia such as aspiration of gastric contents and difficulty with airway management.
Post-spinal anesthesia hypotension in elderly patients is challenging. Correction of Post-spinal anesthesia hypotension by fluids either colloids or crystalloids or by vasoconstrictors pose the risk of volume overload or compromising cardiac conditions. Intravenous Dexamethasone in some studies is used to treat conditions manifested by decrease of peripheral vascular resistance.
Many advantages were investigated for the addition of dexamethasone to bupivacaine in spinal anesthesia as prolongation of anesthesia time, postoperative analgesia and prophylaxis for shivering. Avoidance of complications of opioids is a great issue as, postoperative nausea, vomiting, respiratory depression, urinary retention, prolonged hospital stay and immunosuppression.
In this study the investigators will investigate the ability of dexamethasone to blunt post-spinal anesthesia hypotension in elderly patients undergoing urological endoscopic surgery, and hence, if it decreases amount of fluids and dose of vasoactive drugs.
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
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: > 60 years old
- •Gender: Males and females
- •ASA grade I - II - III
- •Patients undergoing elective endoscopic urological procedures.
排除标准
- •Patient refusal.
- •Suspected massive bleeding.
- •Transition to open abdominal surgery
研究组 & 干预措施
Drug arm
45 patients will receive 8mg dexamethasone in addition to bupivacaine intrathecally .
干预措施: Dexamethasone (Drug)
Drug arm
45 patients will receive 8mg dexamethasone in addition to bupivacaine intrathecally .
干预措施: Bupivacaine Hydrochloride (Drug)
control arm
45 patients will receive only bupivacaine intrathecally as a control group.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Total amount of fluids
时间窗: intraoperative
Total amount of fluids needed to maintain mean blood pressure more than 65 mmHg
Total amount of vasoactive drugs
时间窗: Intraoperative
Total amount of vasoactive drugs needed to maintain mean blood pressure more than 65 mmHg
次要结局
- Blood pressure(Intraoperative and up to 1hour postoperative)
- Post-operative shivering.(Up to 6 hours postoperatively.)
- Post-operative nausea and vomiting.(Up to 6 hours postoperatively.)
- Post dural puncture headache.(Up to 2 days postoperative)
- Post-operative VAS score of pain assessment.(Up to one hour postoperative)
研究者
Dalia Mohamed Abbas
Assistant lecture
Assiut University