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临床试验/NCT06026475
NCT06026475已完成不适用

Role of Goal Directed Fluid Therapy in Enhanced Recovery After Surgery in Gastro-intestinal Onco-surgeries

Rajiv Gandhi Cancer Institute & Research Center, India1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Duration of ICU stay

研究概览

简要总结

Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery and reducing postoperative morbidity after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery .The key elements of ERAS protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens , goal directed fluid therapy early mobilization.

详细描述

For the proposed study investigators plan to include total 60 patients with 30 each allotted to GDFT(SVV) and CVP Group ,belonging to ASA ( American Society of Anesthesiology)Grade I/II/III, study will be conducted after obtaining written informed consent from all patients and approval from the scientific committee and Institutional Review Board (IRB). All patients will receive one-third starvation fluid as crystalloid during first hour of surgery . Night prior to and on the day of surgery carbo load will be given to all patients according to the protocol.Monitoring included 5 lead ECG SPO2,ETCO2, Invasive Blood Pressure (IBP - Radial),CVP(site IJV),core Temperature .

Standard General anaesthesia with oral Endotracheal tube and Intermittent Positive Pressure Ventilation will be given to all patients.Patients will be allotted randomly to either Goal Directed Fluid Therapy (GDFT) /SVV - Stroke Volume Variation or Conventional Central Venous Pressure - CVP guided fluid Therapy Group.

During the surgery - Heart rate , Mean arterial Blood Pressure , Urine output , Blood loss , Seum lactate levels will be noted.

For SVV Group - SVV , Stroke Volume Index (SVI) , Systemic vascular resistance index (SVRI) ,Cardiac Index (CI) values will be noted every 30 minutes- the goal is to maintain SVV value >11 and to give colloid bolus 200ml whenever SVV values rise above11.Pre and post bolus SVV, SV, SVI and SVRI shall be recorded.

For CVP Group - Goal is to maintain CVP values between 8-12 cmsH20 and for decrease in value < 8 colloid bolus of 200ml will be given and change in CVP value will be noted.

研究设计

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

盲法说明

Participant will be masked about allotment of interventional group either CVP or SVV .

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Elective major open gastrointestinal Oncosurgeries .

排除标准

  • •Patient refusal.
  • •Robotic surgery.
  • •Laparoscopic surgery.
  • •Arrythmias.

研究组 & 干预措施

Intraoperative Goal Directed Fluid Therapy (GDFT) guided by Stroke Volume Variation (SVV)

Active Comparator

When SVV values will increase above 11 colloid bolus 200ml will be administered. postbolus change in values of SVV , SV , SVI and CI shall be noted.

干预措施: Goal directed Fluid Therapy (Procedure)

Intraoperative Conventional Fluid Therapy (CFT) guided by Central Venous Pressure (CVP) .

Active Comparator

When CVP values will decrease below 8 cmsH20 colloid bolus 200ml will be administered .Postbolus change in values shall be noted .

干预措施: Conventional Fluid Therapy (Procedure)

结局指标

主要结局

Duration of ICU stay

时间窗: upto 5 days .

Time of shifting of patients in both group to the ward in hours.

Postoperative serum Lactate levels mmol/L

时间窗: upto 48 hours

Serum lactate levels will be measured in the SICU

次要结局

  • Serum Creatinine levels mg/dL.(Upto 48 hours.)

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

Principal Investigator

Rajiv Gandhi Cancer Institute & Research Center, India

研究点 (1)

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