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临床试验/CTRI/2018/04/013247
CTRI/2018/04/013247已完成不适用

ENHANCED RECOVERY AFTER SURGERY(ERAS) IN ELECTIVE CRANIOTOMIES – A PROSPECTIVE COHORT STUDY

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
1.To compare the conventional and ERAS protocol on the post-operative length of ICU stay in patients undergoing elective craniotomies.

研究概览

简要总结

Enhanced Recovery After Surgery protocols have already being established in the field of gastro- enterology and and urological surgeries. Though ERAS guidelines for neurosurgery exist ,no study has been conducted so far to evaluate the implementation of ERAS protocols to neurosurgeries. Here we attempt to implement ERAS protocols  starting from preoperative councelling , carbohydrate preloading , preemptive analgesia , scalp block and scalp infiltration , near zero fluid balance , temperature and glycemic monitoring ,restricted intra and postoperative use of opiods and encouraging removal of unwanted drains and cathethers to 31 cases of supratentorial space occupying lesions posted for elective craniotomies and compare with 31 matched controls done under conventional protocols. The comparison will be made on the basis of length of duration of stay in the ICU , post operative pain scores , post operative glycemic status and overall length of stay in hospital .This will be a prospective cohort study and will give an insight as to the efficacy of ERAS programs with neurosurgery.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •1.Adult patients (>18 years) 2.ASA 1 and 2 functional status 3.Patients undergoing elective craniotomies for supra-tentorial space occupying lesions.

排除标准

  • •1.Refusal to give consent 2.GCS (Glasgow Coma Scale) score <13 3.Uncontrolled diabetics.

结局指标

主要结局

1.To compare the conventional and ERAS protocol on the post-operative length of ICU stay in patients undergoing elective craniotomies.

时间窗: 1.Total duration of stay in ICU | 2.Time of discharge from ICU

次要结局

  • 1.If there was prolonged stay in the ICU 48 hours in both the groups, what was the cause – ie whether it was surgical or non- surgical cause that lead to the prolongation?(2.Whether ERAS protocol had led to decrease in the consumption of opioids and / decreased cumulative analgesic use ?)

研究者

申办方类型
Government medical college

研究点 (1)

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