临床试验/CTRI/2024/04/066005

CTRI/2024/04/066005尚未招募不适用

Enhanced recovery in elective supratentorial craniotomies- a randomised controlled study

SIMS Hospitals1 个研究点分布在 1 个国家目标入组 150 人开始时间: 2024年5月1日最近更新: 2024年4月17日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 150
试验地点: 1
主要终点: Duration of hospital stay and total hospitalisation cost

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The use of ERAS protocol in the study group of patients who satisfy inclusion criteria and determination of duration of hospital stay and total hospitalisation costs when compared to the control group of standard protocol. Duration of length of hospital stay and costs compared along with readmission rates

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•ASA 1 and 2, patients admitted for elective craniotomy for a single intracranial supratentorial lesion.

排除标准

•ASA 3 and 4, patients with major comorbid conditions, obese individuals with BMI more than or equal to 30, patients with drug allergies or egg allergy, patients participating in any other clinical studies, patient with major neurological deficits.

结局指标

主要结局

Duration of hospital stay and total hospitalisation cost

时间窗: From admission to discharge

次要结局

Readmission rates, postoperative complications, postoperative pain scores, perioperative opioid consumption, length of ICU , duration of drainage tube, time to first oral intake, postoperative functional recovery status(30 days from day of discharge)

研究者

发起方

SIMS Hospitals

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Dr Magimairaj

SIMS Hospitals

研究点 (1)

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