Goal-Directed Fluid Therapy in Patients Undergoing Lower Limb Surgeries

Not Applicable

Not yet recruiting

• Conditions: Anesthesia; ERAS; Hypovolemia; Surgical Shock; Fluid Overload
• Interventions: Procedure: standard fluid management; Procedure: Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index

• Registration Number: NCT06133257
• Lead Sponsor: Zagazig University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-10-31
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-10
• Last Update Submitted: 2023-11-10
• Study First Posted: 2023-11-15
• Last Update Posted: 2023-11-15
• Study Start: 2023-12-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C Group	standard fluid management	the standard fluid management group patients will be fasting 6 hours preoperatively and will receive intraoperative fluid in standard manner.
GD Group	Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total fluid intake during operation	intraoperatively	Total fluid intake during operation
Number of patients that needed Ephedrine or Atropine	intraoperatively	Number of patients that needed Ephedrine or Atropine intraoperatively
Length of hospital stay	the patient will be followed up for 60 days from day of surgery	the number of days from day of surgery until patient's discharge from hospital
Peripheral perfusion index	Intraoperatively	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.