Effect of two different doses of Dexmedetomidine intraoperatively on postoperative cognitive dysfunction in elderly patients undergoing major abdominal surgery under General Anesthesia : A randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To determine whether the use of intraoperative Dexmedetomidine is associated with a decreased incidence of post-operative cognitive dysfunction in elderly patients
研究概览
简要总结
Post operative cognitive dysfunction is defined as a new cognitive impairment arising after a surgical procedure. Its diagnosis requires both pre- and post-operative psychrometric testing. The most commonly seen problems are memory impairment and impaired performance on intellectual tasks.
Approximately 25% of all elderly patients having major surgery will have an identifiable fall in cognition and 50%of these patients will suffer a permanent dysfunction.
Dexmedetomidine is a specific and selective alpha-2 adrenoceptor agonist. By binding to presynaptic alpha-2 adrenoceptors, it inhibits the release of norepinephrine, therefore terminating the propagation of pain signals. It also has sympatholytic and sedative effects on the human body.
The MOCA(Montreal Cognitive Assessment scale) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains like attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculation and orientation etc. The total possible score is 30 points, with 26 or above considered as a normal score.
In this study we compare two different doses of Dexmedetomidine based on their effectivity in decreasing the incidence of post operative cognitive dysfunction in elderly patients undergoing major abdominal surgery under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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 belonging to ASA grade I and II.
- •Patients give informed and written consent for surgery.
- •Patients aged 60 years or more.
- •d.Patients undergoing elective abdominal surgeries lasting for 2 or more hours but not more than 4 hours under General Anesthesia.
排除标准
- •Patients belonging to ASA grade III & IV, Patients who refuse consent, Patients with pre existing diagnosis of Schizophrenia or Dementia or any condition which affects cognition, Patients with visual and hearing impairment, Patients with communication barriers who could not complete the cognition test and patients with pre operative Montreal Cognitive Assessment score less than 26.
结局指标
主要结局
To determine whether the use of intraoperative Dexmedetomidine is associated with a decreased incidence of post-operative cognitive dysfunction in elderly patients
时间窗: MOCA scale will be used to assess patients cognition status before surgery | and | 1 hour after surgery | 6 hours after surgery | 24 hours after surgery and preoperative and postoperative cognition scores will be compared
次要结局
- To determine at which dose Dexmedetomidine has a more favourable effect on postoperative cognitive dysfunction and whether Dexmedetomidine plays a role in post operative analgesia.(For 1 hour,6 hours, and 24 hours after end of general anesthesia.)
研究者
Dr Debjit Ghosh
Rajendra Institute of Medical Sciences