Comparative evaluation of dexmedetomidine and magnesium sulphate on propofol consumption, haemodynamics and postoperative recovery in spine surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To study the effect of dexmedetomidine and magnesium sulphate on propofol consumption and haemodynamics in spine surgery.
研究概览
简要总结
Magnesium sulphate and dexmedetomidine have been used during surgery with the intention to maintain haemodynamic stability, decrease anesthetic requirement and improved postoperative recovery in general anesthesia.
Aim - To evaluate the efficacy of dexmedetomidine and magnesium sulphate on propofol consumption, haemodynamics and postoperative recovery in spine surgery.
Desigh - Prospective, randomized, placebo controlled double blinded study
Methods - Ninety patients of both gender undergoing spine surgery under general anesthesia will be randomly assigned to three groups. Group I - Dexmedetomidine loading dose 1 mcg/kg before induction over a period of 15 min and maintenance 0.5 mcg/kg/h throughout the surgery. Group II- Magnesium sulphate loading dose 50 mg/kg before induction over a period of 15 min and maintenance 15 mg/kg/h throughout the surgery. Group III - The same volume of normal saline will be administered . Anesthesia will be induced with midazolam, fentanyl, propofol and vecuronium after 5 min of loading dose of study drug. Anesthesia will be maintained with oxygen, nitrous oxide, intermittent boluses of vecuronium and fentanyl. Neuromuscular blockade will be reversed after completion of surgery. A blinded observer will be recorded haemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure and mean blood pressure) and propofol consumption. Statistical analysis will be done after completion of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA grade I and II, 2.Non hypertensive and non diabetic 3.Scheduled for spinal surgery under general anesthesia.
排除标准
- •1.Known allergy to magnesium sulphate or other study drug, 2.Morbid obesity (body mass index>40), 3.Chronic use of opioids and anticoagulants 4.Current treatment with a β-blocker or calcium channel blocker 5.Diabetes and hypertension 6.Known asthma or reactive airway disease, 7.Hepatic, renal or cardiovascular dysfunction 8.Any degree of heart block 9.Haematological disorder 10.History of neuromuscular disease, 11.Patients receiving magnesium supplementation, 12.Drugs known to have a significant interaction with NMDAs 13.Psychiatric patients 14.Pregnant and lactating women.
结局指标
主要结局
To study the effect of dexmedetomidine and magnesium sulphate on propofol consumption and haemodynamics in spine surgery.
时间窗: (A) Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and bispectral index (BIS) will be continuously monitored and recoreded at following time intervals | 1)Preop | 2)After study drug | 3)After induction | 4)After intubation | 5)Intraop period at 20 min intervals | 6)After surgery | 7) After extubation | (B) Propofol requirement hourly
次要结局
- (1)Postoperative recovery parameters(- Extubation time –)