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临床试验/NCT06418893
NCT06418893招募中2 期

Effect of Isoflurane and Target Control Infusion (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients: A Randomized Controlled Trial.

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively.

研究概览

简要总结

Both isoflurane and propofol are being used to give anaesthesia for living donor liver transplant in our institute. Propofol when compared to isoflurane has advantages like early awakening from anaesthesia, reduced nausea, vomiting in the postoperative period. Propofol also has antioxidant properties. Because of its antioxidant properties propofol may have a protective effect against oxidative stress and ischemia reperfusion injury in major organs during liver transplant surgery. However, there are no studies showing the effect of isoflurane and propofol on Intraoperative hemodynamics and postoperative liver and kidney functions.Thus, we are conducting this study to know the effect of these agents on intraoperative hemodynamics and postoperative liver and kidney function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Above 18 years of age who will undergo living donor liver transplant

排除标准

  • Refusal to consent
  • Acute liver failure, Acute on chronic liver failure
  • Allergic to propofol or any component of propofol
  • Patients with pre existing cardiac dysfunction and cardiomyopathy
  • Patients with pre existing renal dysfunction/ deranged RFTs preoperatively

研究组 & 干预措施

Isoflurane

Active Comparator

Drug- Isoflurane Dosage form- Inhalational, 1-2% Frequency- Continuously Duration- Throughout Intraoperative period

干预措施: Inhalational isoflurane (Drug)

Propofol

Experimental

Drug- Propofol Dosage form- Intravenously, 2.5 mcg/ml target plasma concentration Frequency- Continuously Duration- Throughout Intraoperative period

干预措施: Target control infusion propofol (Drug)

结局指标

主要结局

Comparison of total Noradrenaline and vasopressin requirement between isoflurane and TCI propofol group in Living donor liver transplant recipients intraoperatively.

时间窗: INTRAOPERATIVELY

TCI propofol will provide more stable hemodynamics

次要结局

  • To compare between the two groups cardiac output during different phases of liver transplant recorded every 15 minutes(INTRAOPERATIVELY AT 15 MINUTES INTERVAL)
  • Peak dose of nordrenaline and vasopressin during different phases of liver transplant intraoperatively(Intraoperatively)
  • Postoperative Liver function tests ie Bilirubin and albumin(at 12, 24, 72 hours and day 7 postoperatively)
  • Total vasopressor requirement during reperfusion(Intraoperative)
  • Postoperative Liver function tests ie GGT(at 12, 24, 72 hours and day 7 postoperatively)
  • Postoperative Liver function tests ie platelet count(at 12, 24, 72 hours and day 7 postoperatively)
  • To compare between the two groups mean systemic vascular resistance during different phases of liver transplant recorded every 15 minutes(INTRAOPERATIVELY AT 15 MINUTES INTERVAL)
  • QTc interval between the two groups during different phases of liver transplant measured every 15 minutes(Intraoperatively every 15 mins)
  • Postoperative coagulation profile(at 12, 24, 72 hours and day 7 postoperatively)
  • To compare between the two groups mean arterial pressure during different phases of liver transplant recorded every 15 minutes(INTRAOPERATIVELY AT 15 MINUTES INTERVAL)
  • Postoperative Liver function tests ie AST and ALT(at 12, 24, 72 hours and day 7 postoperatively)
  • Postoperative Renal function tests i.e. Blood urea and S.creatinine levels(at12, 24, 72 hours and day7 postoperatively)
  • Peak lactate levels intraoperatively(Intraoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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