Goal-Directed Fluid Therapy in Patients Undergoing Lower Limb Surgeries

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-08-01

Brief Summary

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

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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.

Conditions

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Anesthesia ERAS Fluid Overload Hypovolemia; Surgical Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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GD Group

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.

Group Type ACTIVE_COMPARATOR

Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index

Intervention Type PROCEDURE

Measuring Inferior vena cava(IVC) diameter using ultrasound then calculation Inferior vena cava(IVC) collapsibility index and administer fluid accordingly.

C Group

the standard fluid management group patients will be fasting 6 hours preoperatively and will receive intraoperative fluid in standard manner.

Group Type ACTIVE_COMPARATOR

standard fluid management

Intervention Type PROCEDURE

standard fluid management

Interventions

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Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index

Measuring Inferior vena cava(IVC) diameter using ultrasound then calculation Inferior vena cava(IVC) collapsibility index and administer fluid accordingly.

Intervention Type PROCEDURE

standard fluid management

Intervention Type PROCEDURE

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes