Goal-Directed Fluid Therapy in Patients Undergoing Lower Limb Surgeries

NCT06133257 | Unknown

• 1 other identifier: 11122
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Anesthesia; ERAS; Fluid Overload; Hypovolemia; Surgical Shock

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Total fluid intake during operation

  intraoperatively

• Number of patients that needed Ephedrine or Atropine

  intraoperatively

• Peripheral perfusion index

  Intraoperatively

• Length of hospital stay

  the patient will be followed up for 60 days from day of surgery

Study Arms (2)

GD Group

ACTIVE COMPARATOR

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

C Group

ACTIVE COMPARATOR

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

Procedure: standard fluid management

Interventions

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

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

GD Group

standard fluid management PROCEDURE

standard fluid management

C Group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Advanced kidney, liver, respiratory or cardiovascular disease.
• Contraindication for spinal anesthesia.
• Patients shifted to general anesthesia for any reason.

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Edema; Hypovolemia; Shock, Surgical

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Postoperative Complications; Shock

Study Officials

• Mahmoud Abdelkader, MBBCh

  Anesthesia, Intensive Care and Pain Management department, Faculty of Medicine, Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Abdelkader, MBBCh

CONTACT

00201553638376; mahmoud.ab.ali@gmail.com

Alshaimaa Kamel, MD.

CONTACT

01005593169; AlshaimaaKamel80@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor of anesthesia, Intensive Care and Pain Management

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 15, 2023
• Study Start: December 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share