Effect of Intraoperative Dexmedetomidine infusion on Postopearative Cognitive Dysfunction and Recovery Quality in an Elderly Patient posted for Spine Surgery: a Randomized Prospective Double Blinded Study
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
- 1.Mini- Mental State Examination (MMSE) Scores.
研究概览
简要总结
This study is aimed to see the ’’ Effect of Intraoperative Dexmedetomidine infusion on Postopearative Cognitive Dysfunction and Recovery Quality in an Elderly Patient posted for Spine Surgery’’
Primary Outcome Variables:
We will assess postoperative cognitive function and quality of recovery utilizing
1. 1. Mini- Mental State Examination (MMSE) Scores.
2. 2. 15-item quality of recovery score (QoR15) questionnaire.
Secondary Outcome Variables:
1. Intraoperative propofol consumption.
2. Intraoperative and postoperative fentanyl requirement.
3. Haemodynamic changes.
On the day of surgery, a baseline neurophysiological testing, using both MMSE (T0) and QoR15 (Q0) scoring would be done at 7:00 am. No sedative premedication will be prescribed. After adequate fasting, the patient will be shifted to the operating theatre where monitors such as electrocardiogram, pulse oximeter, and non-invasive blood pressure cuff will be applied and intravenous (IV) access secured. At this time computer generated randomization table will be used to assign each patient to either the dexmedetomidine group (Group D, n=30) or placebo group (Group P, n=30). A 50 ml syringe containing dexmedetomidine 4mcg/ml in normal saline for Group D or normal saline for Group P will be prepared shortly before induction anaesthesia by an anesthesiologist, who will be the part of study but not involved in the perioperative management of these patients. The study drug infusion will be started by the same anesthesiologist soon after the securing the IV access. Group D will receive IV dexmedetomidine at the rate of 0.5 mcg/kg/hr until beginning of skin closure. Group P will receive volume matched saline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with American Society of Anesthesiologists (ASA) physical status I-III aged 60- 80 years old, undergoing elective lumbar spine surgery.
排除标准
- •1.Patients age less than 60 years and more than 80 years old.
- •2.Patients with a pre-operative or intraoperative ECG (electrocardiogram) that showed severe bradycardia (sinus rhythm, heart rate less than 50/ min) or conduction block 3.Patients with associated renal, hepatic and respiratory dysfunction.
- •4.Patients with history of central nervous system disease such as head injury, stroke, previous neurosurgery, behavioral disturbances or mental retardation.
- •5.Patients with preoperative cognitive dysfunction (MMSE<24) 6.Patients on β-blockers, cimetidine, digoxin, α2-agonists, anticonvulsants or psychotropic medications 7.Patients with allergy to dexmedetomidine or another alpha-2 adrenergic receptor agonist.
结局指标
主要结局
1.Mini- Mental State Examination (MMSE) Scores.
时间窗: 1. Before Anaesthesia | 2. Day 1 of Surgery | 3. Day 2 of Surgery | 4. Day 3 of Surgery
2.15-item quality of recovery score (QoR15) questionnaire.
时间窗: 1. Before Anaesthesia | 2. Day 1 of Surgery | 3. Day 2 of Surgery | 4. Day 3 of Surgery
次要结局
- 1.Intraoperative propofol consumption.(2.Intraoperative and postoperative fentanyl requirement.)