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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-08

Study Completion Date

2022-06-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Goal Directed Fluid Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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

Study Groups

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Stroke Volume Variation 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.

Group Type ACTIVE_COMPARATOR

Intraoperative SVV Guided Fluid Therapy

Intervention Type 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.

Plethysmography Variability Index 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.

Group Type ACTIVE_COMPARATOR

Intraoperative PVI Guided Fluid Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No