Goal-Directed Fluid Therapy in Patients Undergoing Lower Limb Surgeries

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06133257
• Other study ID #: 11122
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: November 2023
• Source: Zagazig University
• Contact: Mahmoud Abdelkader, MBBCh
• Phone: 00201553638376
• Email: mahmoud.ab.ali[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• ERAS
• Fluid Overload
• Hypovolemia
• Shock, Surgical

Intervention

Procedure:
• 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.
• standard fluid management
standard fluid management

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Arterial Blood Pressure	intraoperative mean arterial blood pressure measured in mmHg	intraoperatively every 5 minutes
Primary	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
Primary	Heart Rate	intraoperative heart rate will be continuously monitored and recorded every 5 minutes	intraoperatively every 5 minutes
Primary	Post Anesthesia Care Unit(PACU) Stay	time spent in PACU after surgery measured in minutes	2 hours postoperatively
Secondary	Total fluid intake during operation	Total fluid intake during operation	intraoperatively
Secondary	Number of patients that needed Ephedrine or Atropine	Number of patients that needed Ephedrine or Atropine intraoperatively	intraoperatively
Secondary	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
Secondary	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