跳至主要内容
临床试验/CTRI/2025/07/090920
CTRI/2025/07/090920尚未招募4 期

To determine the effect of Epidural ropivacaine vs fentanyl on Intravenous fluid requirement in patients undergoing renal transplant surgery. A randomized controlled study.

K V Aadhira1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To determine the effect of epidural ropivacaine on Intravenous fluid given intraoperatively as compared with epidural injection of fentanyl.

研究概览

简要总结

Epidural anesthesia is commonly given during renal transplant surgeries and is proven to be safe and effective in mitigating perioperative pain of the patient. Most commonly used drug for the same is local anesthetics like Bupivacaine and Ropivacaine. But many studies have shown lower thoracic epidurals that are normally placed for abdominal surgeries will cause hypotension when local anesthetic drug is given due to its effect on sympathetic blockade resulting in vasodilation, pooling of blood and drop in blood pressure. This mechanism of action is specific to local anesthetic drugs. However, this can be easily treated by giving bolus of Intravenous crystalloids. This study focuses on comparing this fluid requirement seen in Ropivacaine (less cardiotoxic) as compared to Fentanyl which is an opioid that acts via blocking u receptors (not causing vasodilation). As renal transplant recipients have a narrow margin for euvolemic status, studies that further optimise fluid management strategies will benefit the patients directly and indirectly by contributing to the literature. As there is a gap in literature for whether this fluid requirement is significant in the two drugs, we propose studying this in a controlled environment to evaluate the same. The study participants will be recruited after ethics committee approval and clinical trial registration and blinded and randomized into one of the two groups. Intraoperative IV fluids will be given based on dynamic targets like pulse pressure variation and systolic pressure variation and also central venous pressure, heart rate and mean arterial pressure. Any need for vasopressor requirement will be noted and the total Intravenous fluids given to the patient at end of surgery will be noted. The results from two groups will be statistically analysed to determine if the effect of drug is significantly more.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • Patients who have given written and valid consent to participate in study, 2) Age more than 18 years, 3) Patients of either sex, 4) Patients with normal liver function.
  • no jaundice no raised enzymes in lab values and coagulation profile (prothrombin time, activated partial thromboplastin time and INR as per lab values) 5) BMI less than 35 kg per m2, 6) ASA grade of patient 3 or 4 where grade 3 is a patient with severe Systemic disease and grade 4 is a patient with severe Systemic disease that is a constant threat to life.

排除标准

  • Patient refusal, 2) Patients with history of allergy to local anesthetic, 3) Patients undergoing native kidney nephrectomy along with renal transplant 4) CKD patients with cardiomyopathy- hypertrophic or dilated and Heart failure- as defined by Ejection fraction less than 45% and severe breathless at rest and orthopnea 5)Hemodynamically unstable patients with severe hypotension that is baseline BP of less than 90/60 mmHg before surgery, 6) Pregnant patients, 7) Patients with absolute contraindication to epidural catheterization- local site infection in the lumbar region, coagulopathy or bleeding diathesis and severe hypovolemia.
  • Cold Ischemia time more than 16 hours, that is the time from cold perfusate injection after retrieval to reperfusion with recipient blood.

结局指标

主要结局

To determine the effect of epidural ropivacaine on Intravenous fluid given intraoperatively as compared with epidural injection of fentanyl.

时间窗: From Induction of anesthesia to after extubation of patient in kidney transplant recipients. Total IV fluid given will be calculated and noted.

次要结局

  • to evaluate the need for vasopressor requirement to maintain haemodynamic targets when administering epidural ropivacaine as compared to epidural fentanyl during renal transplant surgery(From Induction of anesthesia to the extubation of patient after kidney transplant surgery, the need for vasopressor requirement will be noted.)

研究者

发起方
K V Aadhira
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Kakumanu Venkata Aadhira

Nizams Institute of Medical Sciences

研究点 (1)

Loading locations...

相似试验