A prospective, randomized, double-blinded study comparing the effects of Desflurane and Isoflurane on emergence from anaesthesia and recovery of post-operative motor deficits in patients undergoing elective neurosurgery for supratentorial mass lesions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- i.Time to obeying motor commandsii.Time to extubationiii.Time to eye openingiv.Time to orientationv.Time to recovery of motor deficits
研究概览
简要总结
This study is a prospective, double-blinded randomized controlled trial comparing the effects of 2 inhalational anaesthetic agents - desflurane and isoflurane with regard to emergence and recovery of early neurological deficits in patients undergoing supratentorial craniotomy. Our hypothesis is that desflurane causes quicker emergence from anaesthesia and faster recovery from an early post-operative neurological deficit compared to isoflurane. The study will be conducted on 60 adult (18 ? 70 years, ASA I-III) patients (30 patients in each arm) undergoing elective neurosurgery for supratentorial mass lesions. Primary outcome measures include time to extubation, eye opening, obeying motor commands, orientation and recovery of post-operative motor deficits. Secondary outcome measures include brain relaxation score and number of episodes of hypotension(MAP < 20% baseline), hypertension(MAP>20% baseline) and bradycardia (heart rate <45bpm)
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •a)Elective neurosurgical patients with supratentorial intra-axial mass lesions b)Age 18 -75 years c)ASA grade I.
- •III d)Pre-operative GCS ? 15/15.
排除标准
- •a)Previous craniotomyb)Hepatic or renal disease (elevated SGOT/SGPT/ALP/creatinine)c)Alcohol or drug abused)Hypothyroidism?
- •any thyroid function test outside normal limitse)BMI > 35f)Midline shift > 5mm on CT/MRIg)Female patients ?
- •pregnant/breastfeeding.
结局指标
主要结局
i.Time to obeying motor commandsii.Time to extubationiii.Time to eye openingiv.Time to orientationv.Time to recovery of motor deficits
时间窗: i-iv. At end of surgery v. withing 12 hours after surgery
次要结局
- I. Brain Relaxation Score II. Number Of Episodes Of : Hypotension(MAP < 20% Baseline), Hypertension(MAP>20% Baseline) And Bradycardia (Heart Rate <45bpm)(During the surgery)