Goal-Directed Fluid Therapy in Patients Undergoing Lower Limb Surgeries

Sponsor
Zagazig University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06133257
Collaborator
(none)
52
2
8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index
  • Procedure: standard fluid management
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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.

Active Comparator: C Group

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

Procedure: standard fluid management
standard fluid management

Outcome Measures

Primary Outcome Measures

  1. Mean Arterial Blood Pressure [intraoperatively every 5 minutes]

    intraoperative mean arterial blood pressure measured in mmHg

  2. 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

  3. Heart Rate [intraoperatively every 5 minutes]

    intraoperative heart rate will be continuously monitored and recorded every 5 minutes

  4. Post Anesthesia Care Unit(PACU) Stay [2 hours postoperatively]

    time spent in PACU after surgery measured in minutes

Secondary Outcome Measures

  1. Total fluid intake during operation [intraoperatively]

    Total fluid intake during operation

  2. Number of patients that needed Ephedrine or Atropine [intraoperatively]

    Number of patients that needed Ephedrine or Atropine intraoperatively

  3. 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.

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zagazig University

Investigators

  • Principal Investigator: Mahmoud Abdelkader, MBBCh, Anesthesia, Intensive Care and Pain Management department, Faculty of Medicine, Zagazig University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahmoud Aboubakr Abdelkader, resident doctor of anesthesia, Intensive Care and Pain Management, Zagazig University
ClinicalTrials.gov Identifier:
NCT06133257
Other Study ID Numbers:
  • 11122
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2023