Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. Patients in both the groups will receive Noradrenaline infusion if MAP <70 mmHg with optimal fluid transfusion .Target for transfusing Packed red blood cells will be value of haematocrit < 24 Postoperative HR, MAP, I/O-charting, Serum Creatinine, Serum Lactate, bowel sounds, Inotrope requirement, Visual Analogue Score, Ryles Tube Feeds, Epidural analgesia ,Length of stay (hours in SICU) and any postoperative complications shall be noted. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06026475
Study type Interventional
Source Rajiv Gandhi Cancer Institute & Research Center, India
Contact
Status Completed
Phase N/A
Start date July 13, 2023
Completion date January 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT05070819 - Atrial Natriuretic Peptide in Assessing Fluid Status N/A
Completed NCT05012462 - Clinical Evaluation of the CM-1500 During Apheresis Blood Donation N/A
Completed NCT05463198 - Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600 N/A
Completed NCT06097923 - Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer in Surgical Intensive Care Unit (SICU) N/A
Completed NCT05125848 - Clinical Evaluation of the CM-1500 During Hemodialysis N/A
Completed NCT03133767 - Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation Phase 4
Recruiting NCT05705115 - Acetated Ringer´s Solution in Experimental Hypovolemia Phase 4
Completed NCT03204292 - Evaluating the Fluid Balance of Mechanically Ventilated Patients by Ultrasonography N/A
Completed NCT02052284 - The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants N/A
Enrolling by invitation NCT05278013 - Utility of 2- Octyl Cyanoacrylate (2-OCA) N/A
Completed NCT06101498 - Peroperative Fluid Management in Major Gynecological Cancer Surgeries N/A
Terminated NCT01788293 - Fluid Management Based on Pleth Variability Index (PVI) Monitoring During High-risk Surgery N/A
Completed NCT05740644 - Clinical Evaluation of the Zynex Monitoring System, Model CM-1600 N/A
Completed NCT04598386 - The Effect of AMP Human Sodium Bicarbonate Lotion on Hydration N/A
Completed NCT05980013 - Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500 N/A
Completed NCT05968105 - Changes in Vessels After Peripheral Block
Recruiting NCT03552601 - The Effect of Negatively Fluid Balancing Speed for ICU Patients With Acute Respiratory Distress Syndrome N/A