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

Not Applicable

Completed

• Conditions: Goal Directed Fluid Therapy
• Interventions: Other: Intraoperative PVI Guided Fluid Therapy; Other: Intraoperative SVV Guided Fluid Therapy

• Registration Number: NCT05142163
• Lead Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

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.

Study Timeline

• Study First Submitted: 2021-11-06
• Study Start: 2021-11-08
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-12-02
• Primary Completion: 2022-06-10
• Study Completion: 2022-06-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plethysmography Variability Index Guided Fluid Therapy	Intraoperative PVI Guided Fluid Therapy	Patients will receive maintenance Fluids as crystalloids intraoperative to maintain PVI \<11%, for values \>11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.
Stroke Volume Variation Guided Fluid Therapy	Intraoperative SVV Guided Fluid Therapy	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.

Primary Outcome Measures

Name	Time	Method
To compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group.	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 Outcome Measures

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

Trial Locations

Locations (1)

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 Delhi, India