Effect of Remifentanil Infusion Alone During the Closure Period for Early Emergence and Hemodynamic Stability in Patients Undergoing Supratentorial Craniotomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time of extubation
研究概览
简要总结
Total intravenous anaesthesia using propofol and remifentanil are routinely used drugs for this purpose. The hemodynamic stability and at the same time early emergency are the main goals following neurosurgery. However there is no standard for discontinuation time for manually controlled systems today.
The investigators aimed to study the effect of remifentanil infusion alone for early emergence and hemodynamic stability during the closure period in patients undergoing supratentorial craniotomy.
详细描述
Adult, American society of Anaesthesiologist score I-II, 80 patients who underwent elective supratentorial craniotomy for tumour resection were randomly assigned to group I or II. In group I; propofol was discontinued during the dural closure. After the propofol was discontinued, remifentanil dose was increased with the guidance of bispectral index spectrum and hemodynamic parameters. In group II; propofol discontinued before the end of the surgery. Time to awakening and extubation time, adverse events, total remifentanil and propofol consumptions and side effects were recorded. Heart rate and blood pressure were recorded during this period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiologist physical status I-II
- •Glasgow Coma Scale score of 15 points
- •Elective supratentorial craniotomy for tumor resection
- •Supine position
排除标准
- •Obese patient
- •Brain tumor greater than 30 mm in diameter
- •Postoperative cranial drainage
- •Hypertension
- •Diabetes mellitus
- •Reoperation
- •Breast feeding
- •Allergy to the study medications
- •History of cranial radiotherapy
- •Frontal bone flap
- •Intraoperative neuromonitoring
研究组 & 干预措施
group I
remifentanil
干预措施: Remifentanil (Drug)
group II
remifentanil, propofol
干预措施: Remifentanil (Drug)
group II
remifentanil, propofol
干预措施: Propofol (Drug)
结局指标
主要结局
Time of extubation
时间窗: 3 hours
After the surgery, starting from three-pin head holder removal, an investigator asked each patient to open his or her eyes, squeeze the investigator's hand. When the patient opened his or her eyes, obeyed commands, resumed adequate respiration, hemodynamically stable and bispectral index spectrum \> 70-80 was extubated, and the time will be recorded. The patients will be followed for an expected average of 3 hours.
次要结局
- Heart Rate(6 hours)
- Mean arterial pressure were recorded(6 hours)
- Post-anesthesia awaking time(3 hours)
研究者
Hatice Ture
Associate Professor
Yeditepe University Hospital