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

Goal Directed Fluid Therapy Clinical Trial

— SVV PVI GDFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05142163
• Other study ID #: RGCI/GDFT
• Status: Completed
• Phase: N/A
• Start date: November 8, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: March 2024
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 15, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Goal Directed Fluid Therapy
• Stroke

Intervention

Other:
• Intraoperative 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.
• Intraoperative 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.

Locations

Country	Name	City	State
India	Rajiv Gandhi Cancer Institute and Research Centre	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative Cardiac complication	Requirement of Inotrope Nonadrenaline	upto72 hours
Secondary	Postoperative Respiratory complication	Ventilator support	upto 72 hours
Secondary	Postoperative Renal complication	Increase serum creatinine values	upto72 hours
Secondary	Length of ICU stay	Duration in hours stay in PACU	upto72 hours