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Clinical Trials/NCT05142163
NCT05142163
Completed
Not Applicable

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

Rajiv Gandhi Cancer Institute & Research Center, India1 site in 1 country68 target enrollmentNovember 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Goal Directed Fluid Therapy
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Enrollment
68
Locations
1
Primary Endpoint
To compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group.
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 8, 2021
End Date
June 15, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Responsible Party
Principal Investigator
Principal Investigator

Dr Anita Kulkarni

Senior Consultant

Rajiv Gandhi Cancer Institute & Research Center, India

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Length of ICU stay(upto72 hours)
  • Postoperative Respiratory complication(upto 72 hours)
  • Postoperative Renal complication(upto72 hours)
  • Postoperative Cardiac complication(upto72 hours)
  • To Measure Serum Lactate levels mmol/L in SVV and PVI Group.(upto 72 hours postoperative)

Study Sites (1)

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