CTRI/2024/06/069128尚未招募不适用
An observational study to determine haemodynamic stability and renal outcomes in patients undergoing renal transplantation under either Bispectral Index (BIS) monitored Propofol based Total Intravenous Anaesthesia (TIVA) or Minimum Alveolar Concentration (MAC) monitored Sevoflurane based inhalational anaesthesia.
Apollo Multispeciality Hositals Ltd1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年6月24日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- i. To determine intra-op hemodynamic [Heart Rate (HR), Mean Arterial pressure (MAP), Pulse pressure variation (PPV)] stability by observing every 10 minutes and recovery time, which is the time to awakening at the end of surgery.
研究概览
简要总结
An observational study will be done to determine the haemodynamic stability and renal outcomes in patients undergoing renal transplantation dividing them into two groups. One group will undergo Bispectral index (BIS) monitored Propofol based total intravenous anaesthesia (TIVA) technique and the other group will undergo Minimum alveolar concentration (MAC) monitored Sevoflurane based inhalational anaesthesia technique.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient visiting the Nephrology and renal Transplant Unit of Apollo Multispeciality Hospitals Limited.
- •Patients undergoing renal transplantation.
- •Patients from 18 years to 75 years of age group of either sex will be included.
- •The patients/patients’ caregivers who will give the written consent to participate in the study.
排除标准
- •Renal Transplant recipients with Significant Cardiac disease (Ejection Fraction (EF) less than 40 percent) b.
- •Renal disease with a significant potential for recurrence and early kidney graft loss.
- •Patients of age less than 18 years and greater than 75 years will be excluded.
- •The patients/patients caregivers who will not give the written consent to participate in the study.
结局指标
主要结局
i. To determine intra-op hemodynamic [Heart Rate (HR), Mean Arterial pressure (MAP), Pulse pressure variation (PPV)] stability by observing every 10 minutes and recovery time, which is the time to awakening at the end of surgery.
时间窗: 2 hours 40 minutes
次要结局
- i. To determine post-operative Haemodynamics, Urine Output, O2 requirement & Sensorium for 48 hours(ii. To determine Magnesium (Mg), Calcium (Ca) & Trajectory for Creatinine from 48 hours till 7 days)
研究者
Dr Anirban Mandal
Apollo Multispeciality Hospitals Ltd.
研究点 (1)
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