Comparison of effect of opioid free anaesthesia with conventional opioid based anaesthesia in major spine surgery : A Randomized Comparative trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the total dose of rescue analgesic requirement up to 48 hours post operatively after major spine surgery.
研究概览
简要总结
This study is to compare the effects of opioid free anaesthesia with conventional opioid based anaesthesia in patient undergoing to major spine surgery .
Two groups one is opioid based groups in which fentanyl is use as bolus before the induction of general anaesthesia and intravenous infusion of fentanyl will be started during intraoperative period. than all vital parameters and VAS will be noted .Second groups is opioid free groups in which Dexmedetomidine and lignocaine will be used as bolus and infusion during the intraoperative periods. And all haemodynamic parameters and VAS will be noted. than extubation done .Modified aldrete score will be noted in both the groups. Then total dose of rescue analgesia requirement will be noted upto the 48 hours in spine surgery. In rescue analgesia injection diclofenac intravenous given along with paracetamol infusion if VAS more than 4 and total doses of intravenous diclofenac will be compared in both groups. We will also noted the post operative pain intensity and SBP, DBP, MAP, HR, SPO2 upto 48 hours at specific interval time , side effects and total length of hospital stay , compare in both groups. These are compare in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ The Patients of age ≥18-70 yrs of either gender of ASA category 1,2 and 3 undergoing major spine surgery under general anaesthesia who are haemodynamically stable and declared fit in pre- anaesthetics checkup.
排除标准
- •Patient refusal, Patient having known history to allergy to dexmedetomidine, lignocaine and fentanyl and other anaesthetic drugs, patient with history of substance abuse, patient psychiatric illness, cardiac and hepatic insufficiency.
结局指标
主要结局
To compare the total dose of rescue analgesic requirement up to 48 hours post operatively after major spine surgery.
时间窗: To compare the total dose of rescue analgesic requirement up to 48hours post operatively. From the time patient wakes up from anesthesia to 48 | hours post operatively. When VAS is more than 4
次要结局
- Postoperative pain intensity by visual analogue score in both the groups.(Hemodynamic stability and respiratory parameters (SBP, DBP, MAP, HR, SPO2).)
研究者
Dr. Pramilla Soni
Dr S N Medical college jodhpur