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Completed

NCT Number: NCT05142163

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

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

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Key information

Conditions

Goal Directed Fluid Therapy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, 110085, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative SVV Guided Fluid Therapy

Other

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.

Intraoperative PVI Guided Fluid Therapy

Other

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. To Measure Serum Lactate levels mmol/L in SVV and PVI Group.

    Time frame: upto 72 hours postoperative

    Intraoperative at beginning and end of surgery and upto 72 hours serum Lactate levels will

    be measured.

  2. Postoperative Cardiac complication

    Time frame: upto72 hours

    Requirement of Inotrope Nonadrenaline

  3. Postoperative Respiratory complication

    Time frame: upto 72 hours

    Ventilator support

  4. Postoperative Renal complication

    Time frame: upto72 hours

    Increase serum creatinine values

  5. Length of ICU stay

    Time frame: upto72 hours

    Duration in hours stay in PACU

Sponsors and collaborators

Lead sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Other

Registry information

Acronym: SVV PVI GDFT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2021
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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