Comparison Of Enhanced Recovery After Surgery(ERAS) Protocol Vs Conventional Care In Patients Undergoing Elective Craniotomy For Intracranial Aneurysms: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- length of stay in hospital
研究概览
简要总结
This study is a randomized control trial, single center study comparing the efficacy of enhanced recovery after surgery (ERAS) protocol vs conventional care in 46 patients who will be undergoing elective craniotomy for intracranial aneurysm that will be conducted in neurosciences centre , All India institute of medical sciences, New Delhi. The primary outcome measures will be length of stay in hospital. Secondary outcomes will be Intraoperative fentanyl consumption, Postoperative pain assessment by Numerical Rating Score (NRS) pain score every 2 hours for 24 hours, Postoperative analgesic requirement in 24 hours, Postoperative antiemetic requirement in 24 hours, Length of ICU stay, Any Complications (surgical and non-surgical) till discharge, Functional recovery at discharge,1month and 3 months and Patient satisfaction score at discharge
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient who gives Informed Consent 2.Patients with anterior circulation aneurysms with World Federation of Neurosurgical Societies(WFNS) grade 1 3.ASA grade 1 and 2 4.GCS 15/15.
排除标准
- •1.Patients not giving consent 2.Patients with posterior circulation aneurysm 3.World Federation of Neurosurgical Societies (WFNS) grade 2,3,4 and 5 4.Age less than 18 years and more than 65 years 5.ASA grade 3,4,5 6.Pregnant patients 7.Patient requiring postoperative ventilation 8.History of previous brain surgery 9.Preoperative cognitive dysfunction 10.
结局指标
主要结局
length of stay in hospital
时间窗: at discharge
次要结局
- Functional recovery(discharge,1 month and 3 months)
- Patient satisfaction score(discharge)
- postoperative complications both surgical(surgical site infection, intracranial infection, epilepsy, haemorrhage, rebleeding , vasospasm etc) and non-surgical complications (respiratory complications, cardiovascular complications gastrointestinal complications, urinary tract complications, and venous thromboembolism etc )(at discharge)
- Antiemetic requirement in 24 hours(In Postoperative period at 24 hours)
- Length of ICU stay(duration of stay in ICU after surgery)
- Fentanyl consumption
- Pain assessment by Numerical Rating Score (NRS) pain score(In Postoperative period at every 2 hour interval for 24 hours)
- Analgesic requirement(In Postoperative period at 24 hours)