A Prospective Study To Compare The Effect OF Intraoperative Sedation With Dexmedetomidine Versus Ketamine On Postoperative Delirium And Expression Of Inflammatory Markers In Elderly Patients Undergoing Hip Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Proportion of patients developing postoperative delirium as assessed by DSM -5 criteria in both the groups i.e., group D and group K
研究概览
简要总结
Delirium is a common postoperative complication that occurs in 5 to 52% of older adult patients after noncardiac surgery.Delirium is characterized by disturbance in attention, awareness, and cognition that develops acutely and fluctuates frequently throughout the course of the condition..Various pharmacological modalities like typical and atypical antipsychotics, alpha 2 agonists like dexmedetomidine and non-pharmacological techniques like early mobilization, adequate nutrition and sleep hygiene have been employed for the prevention of delirium.
Dexmedetomidine (DEX) is a highly selective α2-receptor agonist that provides sedation, analgesia, and anxiety relief. As an α2-adrenergic receptor agonist, Dexmedetomidine can also reduce the systemic inflammatory response and regulate the immune system by inhibiting the central sympathetic nervous system. Ketamine is a non-competitive NMDA receptor antagonist and also possess neuroprotective and antidepressant property.It has been reported in systematic reviews that intraoperative ketamine administration reduces postoperative markers of inflammation as well as postoperative pain and opioid consumption.Furthermore, delirium and depression in elderly people appear to be overlapping syndromes caused by similar pathophysiological mechanisms.In addition to these theoretical benefits, ketamine is inexpensive and there is extensive experience among anaesthetists internationally.Therefore, dexmedetomidine and ketamine can play a role in reducing the incidence of postoperative delirium in elderly patients undergoing hip surgeries alongside with the levels of pro inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing lower limb surgery under central neuraxial blockade; age more than 60 years; ASA physical status grade I- III.
排除标准
- •Patients with a history of psychosis or long-term psychotropic medication use/ benzodiazepine use/chronic analgesic drugs, or history of alcohol/nicotine abuse.
- •Patients with evidence of severe infection (Total leucocyte count more than 14000 cells/cu.mm).
- •Patients with communication barrier (severe audiovisual impairment or inability to speak or inability to understand Hindi or English language).
- •Baseline Mini-Mental State Examination (MMSE) score of less than or equal to 23.
结局指标
主要结局
Proportion of patients developing postoperative delirium as assessed by DSM -5 criteria in both the groups i.e., group D and group K
时间窗: baseline and at postoperative day 2
次要结局
- Change in levels of IL-6 in pg/ml and CRP in mg/ml from preoperative period to postoperative day 2 (T2) in both the groups.(Proportion of patients developing intraoperative side effects such as bradycardia, tachycardia, hypertension, hypotension and desaturation in both the groups.)
研究者
Vignesh A S
Lady Hardinge Medical College