Goal-Directed Fluid Therapy in Patients Undergoing Lower Limb Surgeries

Study Overview
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Brief Summary
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Controlling the amount of fluids given to patients in perioperative setting can significantly influence their outcomes.

Detailed Description
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To overcome these problems and avoid the complications of over or underhydration, we use the Goal-directed fluid therapy(GDFT) guided by Inferior vena cava(IVC) collapsibility index approach in which dynamic parameters of volume responsiveness as a guide for fluid therapy. This will ensure that the fluids given were deficient from the circulation and improve the recovery of the patients according to enhanced recovery after surgery(ERAS) protocols.

Official Title
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Effects of Goal-Directed Fluid Therapy Guided by Inferior Vena Cava Collapsibility Index on Hemodynamics and Enhanced Recovery in Patients Undergoing Lower Limb Surgeries

Conditions
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Anesthesia, ERAS, Fluid Overload, Hypovolemia; Surgical Shock

Intervention / Treatment
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* Procedure: Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index
* Procedure: standard fluid management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient's acceptance. Patients planned for elective lower limb surgery under spinal anesthesia. Both sexes Body Mass Index(BMI): <35 Age: 21   65 years American Society of Anesthesiologists(ASA) Physical Status Classification System: Class I & II Duration of surgery 2 3 hours Exclusion Criteria: Advanced kidney, liver, respiratory or cardiovascular disease. Contraindication for spinal anesthesia. Patients shifted to general anesthesia for any reason.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GD Group<br>Patients will take oral clear fluids with carbohydrates content 2 hours preoperatively and intraoperative fluid intake will be guided by Inferior vena cava(IVC) diameter. | Procedure: Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index<br>* Measuring Inferior vena cava(IVC) diameter using ultrasound then calculation Inferior vena cava(IVC) collapsibility index and administer fluid accordingly.<br>|
| Active Comparator: C Group<br>the standard fluid management group patients will be fasting 6 hours preoperatively and will receive intraoperative fluid in standard manner. | Procedure: standard fluid management<br>* standard fluid management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Blood Pressure | intraoperative mean arterial blood pressure measured in mmHg | intraoperatively every 5 minutes | 
| Quality of Recovery-40 score(QoR-40) | QoR-40 score ranges from 40 to 200, the higher the score the better the outcome | 24 hours postoperative | 
| Heart Rate | intraoperative heart rate will be continuously monitored and recorded every 5 minutes | intraoperatively every 5 minutes | 
| Post Anesthesia Care Unit(PACU) Stay | time spent in PACU after surgery measured in minutes | 2 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fluid intake during operation | Total fluid intake during operation | intraoperatively | 
| Number of patients that needed Ephedrine or Atropine | Number of patients that needed Ephedrine or Atropine intraoperatively | intraoperatively | 
| Peripheral perfusion index | Peripheral Perfusion Index (PPI) is defined as the ratio of pulsatile blood flow to the non-pulsatile blood flow. It ranges from 0.02% to 20% and it is measured using specific types pulse oximetry and it reflects the perfusion status of the body. | Intraoperatively | 
| Length of hospital stay | the number of days from day of surgery until patient's discharge from hospital | the patient will be followed up for 60 days from day of surgery |