Comparison Of Pharmacological Neuroprotection Provided By PROPOFOL VERSUS DESFLURANE For Long Term Postoperative Cognitive Dysfunction In Patients Undergoing Surgery For Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of cognitive function at one month following surgery.
研究概览
简要总结
Aneurysmal subarachnoid hemorrhage (aSAH) is characterized by the rupture of an intracranial aneurysm and accumulation of blood in the subarachnoid space with 30 to 40% mortality rate. Amongst the survivors 40-50% suffers disability due to cognitive decline.Trends towards early surgery offers challenge to anesthesiologist to provide optimum brain relaxation and simultaneously maintaining stable hemodynamics. Anesthetic agents are administered to conduct smooth neurosurgical procedure. These agents may affect patient's cognitive function postoperatively.Currently most common anesthetic agents used are either intravenous hypnotic agents (propofol) or volatile inhalational agents (isoflurane/sevoflurane/desflurane). Provision of neuroprotection with propofol and volatile inhalational agents has been studied by various authors.Not many studies have been performed in patients undergoing aneurysmal clipping surgeries looking into effects of various anesthetic agents on intraoperative (I/O) brain condition, I/O hemodynamic and POCD.Thus present study is planned to compare propofol and desflurane for long term postoperative cognitive decline in patients undergoing surgery following aneurysmal subarachnoid hemorrhage.
详细描述
100 patients will be randomized into two groups, Desflurane group (Group D) and Propofol group (Group P) using a computer generated algorithm. Written informed consent will be taken from all the patients.
Cognition assessed using MOCA (Montreal Cognitive Assessment)test. A preoperative assessment for establishing the patient's baseline performance. Surgery-related factors may affect test performance if performed too early to reduce possibility of confounding factors, we planned to conduct the test for POCD at the time of discharge of the patient after surgery. To compare long term protection provided by anesthetic agent cognitive functions were assessed at one month following surgery.
Cognitive functions will be assessed at following time period A) Preoperatively B) Postoperatively B1- At the time of discharge B2- 1month after discharge following surgery.
Biomarker levels S100B levels were also measured A) Preoperatively B) Intraoperatively - post clipping C) Postoperatively - 1hour after surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for aneurysmal SAH surgery with clinical and radiological evidence of cerebral aneurysm.
- •Age between 18 to 65 yrs.
- •World Federation of neurosurgery grade 1,
- •American society of Anesthesia grade 1, 2 and 3.
排除标准
- •Co-morbidities other than hypertension and diabetes mellitus like cardiovascular disease and respiratory impairment.
- •Patients with known psychiatric disease.
- •History of drug abuse.
- •Low level of education (illiterate) or multiple failures in school.
- •Patients who are unconscious, intubated or tracheostomised even after two weeks following exposure to anesthesia will also be excluded from the study.
- •Intraoperative complications like massive blood loss, prolonged clipping time(>20minutes), severe intraoperative brain swelling precluding replacement of bone flap.
- •Patients with infectious diseases and respiratory complications.
- •Multiple surgeries.
研究组 & 干预措施
PROPOFOL
Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP(Intracranial pressure) Better cognitive Function preservation
干预措施: Propofol (Drug)
DESFLURANE
Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation
干预措施: Desflurane (Drug)
结局指标
主要结局
Assessment of cognitive function at one month following surgery.
时间窗: One month
Montreal Cognitive Assessment scale is used
次要结局
- Assessment of cognitive function preoperatively Assessment of cognitive function at discharge. Comparison of biomarker of cognitive dysfunction(Baseline cognition assessment prior to surgery)
- Comparison of biomarker (S-100B) levels(Prior to surgery , After clipping of aneurysm, One hour after completion of surgery)
- Assessment of cognitive function preoperatively Assessment of cognitive function at the time of discharge from hospital(Discharge from hospital)
研究者
Dr Shalvi mahajan
Senior Resident
Post Graduate Institute of Medical Education and Research, Chandigarh