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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05142163
Acronym
SVV PVI GDFT
Enrollment
68
Registered
2021-12-02
Start date
2021-11-08
Completion date
2022-06-15
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Goal Directed Fluid Therapy

Keywords

Goal directed Fluid Therapy, Stroke Volume Variation, Plethysmography

Brief summary

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

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.

Interventions

OTHERIntraoperative SVV Guided Fluid Therapy

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.

OTHERIntraoperative PVI Guided Fluid Therapy

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.

Sponsors

Rajiv Gandhi Cancer Institute & Research Center, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

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

Intervention model description

Patients were allotted to either SVV Guided or PVI Guided Intraoperative Fluid Therapy

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group.upto 8 hoursPatients 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

MeasureTime frameDescription
To Measure Serum Lactate levels mmol/L in SVV and PVI Group.upto 72 hours postoperativeIntraoperative at beginning and end of surgery and upto 72 hours serum Lactate levels will be measured.
Postoperative Cardiac complicationupto72 hoursRequirement of Inotrope Nonadrenaline
Postoperative Respiratory complicationupto 72 hoursVentilator support
Postoperative Renal complicationupto72 hoursIncrease serum creatinine values
Length of ICU stayupto72 hoursDuration in hours stay in PACU

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026