Comparison of Desflurane and Propofol for Brain Relaxation in Patients Undergoing Supratentorial Craniotomy：a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Proportion of satisfactory brain relaxation
研究概览
简要总结
Optional brain relaxation improves the surgeon's operating conditions and is likely to minimize the degree of retraction injury ,with the potential for providing patients with a better outcome. The choice of anesthetic drugs can affect intraoperative brain relaxation. Propofol suppresses brain metabolism, reduces cerebral blood flow, and provides satisfactory brain relaxation. Desflurane is often criticized in neurosurgery due to its cerebral vasodilation and potential to increase intracranial pressure, however, it has been found to have a little clinical significance. This study intends to compare the effects of desflurane with propofol on brain relaxation in patients with supratentorial tumors under mild hyperventilation, and to provide new clinical evidence for the use of desflurane in neurosurgical anesthesia.
详细描述
To compare the effect of desflurane versus propofol combined with remifentanil anesthesia on brain relaxation in patients undergoing supratentorial tumor surgery with mild hyperventilation, and compare the emergence time and common complications during recovery.
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
- Double (Participant, 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
- •18-60 years
- •Scheduled for elective craniotomy for supratentorial cerebral tumors
- •ASA status I-III
- •Glasgow score of 15
- •No clinical signs of intracranial hypertension
- •Preoperative brain imaging (CT or MRI) with midline shift less than 5mm
- •Informed consent signed by patients
排除标准
- •Scheduled intraoperative motor evoked potential monitoring
- •Patients with cerebral vascular diseases
- •Uncontrolled cardiopulmonary disease
- •Schedule to retain tracheal intubation after surgery
- •Unable to comprehend and cooperate with the examination
- •BMI > 30 Kg/m-2
- •Emergency surgery
- •History of related anesthetic allergy
研究组 & 干预措施
Desflurane inhalational anesthesia
干预措施: Desflurane (Drug)
Propofol total intravenous anesthesia
干预措施: Propofol (Drug)
结局指标
主要结局
Proportion of satisfactory brain relaxation
时间窗: during surgery
Assessed by the neurosurgeon using a 4-point scale (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain) at the opening of the dura mater, score 1 and 2 represent satisfactory brain relaxation
次要结局
- Dural tension(during surgery)
- Quality of anesthesia recovery(at postoperative day 1)
- Early postanesthesia cognitive recovery(at 15, 30min after tracheal extubation)
- Emergence time(from drug discontinuation to eye opening, assessed up to 1 hours)
- Postoperative complications(from drug discontinuation to discharge from PACU (Postanesthesia care unit), assessed up to 3 hours)
- Duration in PACU (Postanesthesia care unit)(from entering PACU to exiting PACU, an expected average of 1 hour)
- Anesthesia expenses(at postoperative day 1)
- Extubation time(from drug discontinuation to tracheal extubation, assessed up to 1 hours)
- Postoperative pain and postoperative nausea and vomiting (PONV)(during the PACU stay and postoperative day 1.)
研究者
Ruquan Han
Professor
Beijing Tiantan Hospital