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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Goal Directed Fluid Therapy

Intervention / Treatment
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* Other: Intraoperative SVV Guided Fluid Therapy
* Other: Intraoperative PVI Guided Fluid Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing Open major Oncosurgeries under General Anaesthesia Exclusion Criteria Patient Refusal Left ventricular Ejection Fraction <40% Cardiac arrythmias Severe valvular heart disease Peripheral Vascular Disease Laparoscopic surgeries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were allotted to either SVV Guided or PVI Guided Intraoperative Fluid Therapy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stroke Volume Variation Guided Fluid Therapy<br>Patients will receive maintenance Fluids as crystalloids intraoperative to maintain SVV <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted. | Other: Intraoperative SVV Guided Fluid Therapy<br>* Patients will receive intraoperative maintenance Fluids as crystalloids to maintain SVV <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.<br>|
| Active Comparator: Plethysmography Variability Index Guided Fluid Therapy<br>Patients will receive maintenance Fluids as crystalloids intraoperative to maintain PVI <10%, for values >10%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted. | Other: Intraoperative PVI Guided Fluid Therapy<br>* Patients will receive intraoperative maintenance Fluids as crystalloids to maintain PVI <10%, for values >10%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group. | 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. | upto 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Measure Serum Lactate levels mmol/L in SVV and PVI Group. | Intraoperative at beginning and end of surgery and upto 72 hours serum Lactate levels will be measured. | upto 72 hours postoperative | 
| Postoperative Cardiac complication | Requirement of Inotrope Nonadrenaline | upto72 hours | 
| Postoperative Respiratory complication | Ventilator support | upto 72 hours | 
| Postoperative Renal complication | Increase serum creatinine values | upto72 hours | 
| Length of ICU stay | Duration in hours stay in PACU | upto72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Goal directed Fluid Therapy, Stroke Volume Variation, Plethysmography