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临床试验/NCT05142163
NCT05142163已完成不适用

Stroke Volume Variation and Plethysmography Variability Index as Goal Directed Fluid Therapy in Major Oncosurgeries

Rajiv Gandhi Cancer Institute & Research Center, India2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
To compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group.

研究概览

简要总结

Patients were allotted to two Groups , SVV Guided Fluid Therapy Group received intraoperative fluids to maintain SVV <11 , and PVI Guided Group received intraoperative Fluids to maintain PVI<11

详细描述

Preinduction Epidural catheter will be placed and Standard General Anaesthesia with Volume Controlled Ventilation (Tidal Volume 8ml/Kilogram ) and Positive End Expiratory Pressure 5 centimeters of water for all patients. Postinduction Radial artery cannulation and Ultrasound guided Internal Jugular cannulation will be performed for all patients .Maintenance Fluid crystalloids 2ml/kg will be given to both the Groups. In Stroke Volume Variation SVV Group Flotrac Transducer (MHD8 model Edwards Lifesciences LLC, Irvine,CA 92614,USA) will be attached to radial artery cannula to obtain SVV values and for values > 11 colloid bolus 200ml will be given over 10 minutes and postbolus values noted. In Plethysmography Variability Index PVI Group pulse Oximeter will be placed on index finger and covered to avoid ambient light will be attached to Masimo Radical 97 Monitor to measure continuous Perfusion Index and Plethysmography Variability Index for values >11 colloid bolus 200ml will be given over 10 minutes and change in PVI value noted. Intraoperative heart rate , Mean arterial Pressure , Oxygen Saturation, End tidal carbon dioxide, Central venous pressure , Urine output will be measured in all patients.With optimal fluids if Mean Arterial Pressure is below 70 mmHg than titrating dosage Norepinephrine infusion will be commenced.At the end of surgery reversal agents will be administered and trachea extubated , note will be made of any patient requiring postoperative ventilator support.Arterial blood gas analysis will be performed at beginning and end of surgery and at postoperative 24 and 48 hours to measure serum lactate levels . Patient will be monitored in Postanaesthesia Care Unit for any Cardiac , Respiratory event , Serum Creatinine levels will be measures at 24 and 48 hours , Appearance of bowel sounds will be noted , Length of ICU stay will be recorded for all patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Patient were masked about belonging to SVV Guided or PVI Guided Group to receive Intraoperative Fluid Therapy

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing Open major Oncosurgeries under General Anaesthesia

排除标准

  • Patient Refusal
  • Left ventricular Ejection Fraction <40%
  • Cardiac arrythmias
  • Severe valvular heart disease
  • Peripheral Vascular Disease
  • Laparoscopic surgeries

结局指标

主要结局

To compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group.

时间窗: upto 8 hours

Patients in SVV Group will receive Crystalloids and colloid bolus 200ml to maintain SVV \<11 .Patients in PVI Group will receive Crystalloids and colloid bolus to maintain PVI\<11, Postbolus response to SVV and PVI values will be noted.

次要结局

  • Length of ICU stay(upto72 hours)
  • Postoperative Respiratory complication(upto 72 hours)
  • Postoperative Renal complication(upto72 hours)
  • Postoperative Cardiac complication(upto72 hours)
  • To Measure Serum Lactate levels mmol/L in SVV and PVI Group.(upto 72 hours postoperative)

研究者

发起方
Rajiv Gandhi Cancer Institute & Research Center, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Anita Kulkarni

Senior Consultant

Rajiv Gandhi Cancer Institute & Research Center, India

研究点 (2)

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