Anesthetic Method and Cerebral Outcomes: A Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- NSE serum level in PACU
研究概览
简要总结
Research regarding the effects of anesthesia on the central nervous system remain controversial with some studies suggesting a neurotoxic effect and others indicating a neuroprotective effect.
In recent years numerous neuronal proteins have been found to be useful tools for diagnosis and prognosis of cerebral tissue damage. Among these neuronal proteins are the following markers: Neuron Specific Enolase (NSE), Tau protein, Glial Fibrillary Acidic Protein (GFAP), Ubiquitin Carboxy-Hydrolase L1 (UCH-L1).
BIS is a non-invasive brain monitoring technology which monitors the depth of anesthesia.
In this randomized clinical trial, we aim to examine the effect of anesthetic method (General anesthesia and neuroaxial anesthesia) on neuronal damage as measured by NSE serum levels.
One hundred and forty patients aged 18 and above undergoing Transurethral resection of the prostate, Trans Urethral Resection of the Bladder Tumor, Tension Free Vaginal Tap , Trans Obturator Tension Free Vaginal Tap and pelvic floor repair surgeries will be enrolled in the study.
Patients will randomly be assigned to undergo the study either under general anesthesia or with neuroaxial anesthesia.
Participants will be monitored using the BIS monitor, to measure the depth of anesthesia.
Additionally, 9 cc of venous blood be collected from each participant in the surgery room prior to anesthesia induction, throughout anesthesia and one hour following surgery in the PACU in order to assess NSE levels.
详细描述
I
Specific Aim:
Primary Endpoint Our primary endpoint is to compare the effect of anesthetic method (GA vs. NA) on plasma level of neuronal damage biomarker NSE.
Study Design:
This is a prospective, single center, randomized controlled trial that try to assess the effect of anesthetic method on neuronal damage biomarker level. The study will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will conducted in Beilinson Hospital . All patients above 18 presenting for primary TURP, TURBT, TVT, TVT-O and pelvic floor repair surgeries. All patients who are able to comply with the study requirements and gave a written informed consents.
排除标准
- •Patients with a history of a cerebrovascular accident (CVA) or Transient ischemic attack (TIA) in the year prior to surgery.
- •Patients with significant decreases in cognitive function prior to surgery.
- •Patients presenting for a secondary TURB surgery.
- •Patient with a contraindication to NA.
- •Patients who are unable to sign an informed consent form.
结局指标
主要结局
NSE serum level in PACU
时间窗: 1 hour after surgery completion
次要结局
- NSE serum levels after anesthesia induction(Half an hour after anesthesia induction)
研究者
Leonid Eidelman
Professor
Rabin Medical Center