Comparison of effects of intravenous infusion of dexmedetomidine versus low dose ketamine- dexmedetomidine combination on spinal block, surgical stress response and discharge readiness from pacu in orthopedic patients- a prospective, randomized controlled clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the time of regression of sensory blockade to S1 between the two groups
研究概览
简要总结
We will be comparing the effects of intravenous infusion of Dexmedetomidine versus low dose Ketamine & Dexmedetomidine infusion on spinal block in lower limb orthopedic surgeries titrating the dose of Dexmedetomidine to maintain a Ramsay sedation score of 3-4. Patients will be selected based on the inclusion and exclusion criteria as mentioned above. Statistical analysis will be performed by using SPSS statistical software version 22.0 and R.3.2.0 and results will be tabulated in a Microsoft Office Excel worksheet. T-test will be used for comparing the parameters between the groups. This study helps in identifying whether low dose ketamine-dexmedetomidine combination is superior to dexmedetomidine alone in managing postoperative analgesia and hemodynamic stability in orthopedic surgeries under spinal anaesthesia. There are no studies on intravenous ketamine-dexmedetomidine combination in patients under spinal anaesthesia. If proven effective, the combination of dexmedetomidine-ketamine can be very useful in reducing patient length of stay in PACU and reduce hospital costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients of age 18-65 years, BMI 18-30 having an ASA physical status of either 1 or 2, posted for elective orthopedic lower limb surgeries under spinal anaesthesia will be included in this study.
排除标准
- •1.Patients with prior addiction or analgesic abuse (opioid and non-steroidal anti-inflammatory drug medications).
- •2.Patients with a history of psychiatric or neurological disease, deafness.
- •3.Patients who do not achieve a sensory level of T10 or above.
- •4.Patients who do not achieve Modified Bromage scale of 1-
- •5.Patients complaining of pain within 60 minutes of the start of surgery.
- •6.Patients with difficult spinal requiring more than 3 attempts.
- •8.Patients requiring supplementation with general anaesthetic agents.
结局指标
主要结局
To compare the time of regression of sensory blockade to S1 between the two groups
时间窗: Every 30 minutes postoperative till regression to S1 is achieved
次要结局
- 1.To compare the intraoperative hemodynamic stability between the two groups.(2.To compare the change in perioperative stress markers in preoperative and postoperative period between the two groups.)