Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension

Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension: A Randomized Controlled Trial

Hypotension is a common side-effect of general anesthesia induction and is related to adverse outcomes including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury.Half of all the patients were fluid-responsive, pointing to volume status as a significant risk factor. Ultrasound measurements of inferior vena cava (IVC) diameter with respiration, including the maximal diameter of the IVC (dIVCmax) at the end of expiration during spontaneous respiration and the collapsibility index (CI), have been recommended as rapid and noninvasive methods for estimating volume status.

In attempt to prevent hypotension after spinal anesthesia induction, Ondansetron, a serotonin receptor antagonist, has been used effectively .

Research Question Can preoperative IVC-US guided fluid optimization and intravenous ondansetron reduce the incidence of general anesthesia-induced hypotension in adult patients undergoing elective non-cardiac non-obstetric surgery?

Study Overview

• Status: Not yet recruiting
• Conditions: Intra-operative Hypotension
• Intervention / Treatment: Drug: fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Dichtwald, Dr; Phone Number: 1 972-9-7472133; Email: sara.dichtwald@clalit.org.il

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age > 18
2. Elective, non-cardiac, non-obstetric surgery under general anesthesia
3. American Society of Anesthesiologists physical status classification I - III

Exclusion Criteria:

1. MAP below 60 mmhg prior to the induction of general anesthesia.
2. Patients treated with angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB) on the day of surgery.
3. Patients with heart failure with ejection fraction (EF) < 40%.
4. Patients with documented acute or chronic renal failure.
5. Patients with hepatic failure.
6. Patients with neuraxial (spinal/epidural) anesthesia performed before induction of general anesthesia.
7. Patients with suspected difficult airway.

8. Patients with documented allergy to Ondansetron or prolonged QT-syndrome.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
Active Comparator: Intravenous fluid bolus	Drug: fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone; group A will undergo fluid repletion guided by their IVC-CI - if a collapsible IVC, defined as a CI equal or greater than 43%, is observed, patients will receive repeated Lactated Ringer's 500 ml boluses followed by repeated IVC-CI measurements until their CI is less than 43%, and up to 1.5L. Group B will undergo the same intervention, with the addition of intravenous ondansetron 4 mg in 10 ml normal saline 20 minutes before induction of general anesthesia.
Active Comparator: Intravenous Ondansetron	Drug: fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone; group A will undergo fluid repletion guided by their IVC-CI - if a collapsible IVC, defined as a CI equal or greater than 43%, is observed, patients will receive repeated Lactated Ringer's 500 ml boluses followed by repeated IVC-CI measurements until their CI is less than 43%, and up to 1.5L. Group B will undergo the same intervention, with the addition of intravenous ondansetron 4 mg in 10 ml normal saline 20 minutes before induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of preoperative IVC-guided fluid optimization and intravenous ondansetron in reducing the incidence of hypotension after the induction of general anesthesia	To determine the efficacy of preoperative IVC-guided fluid optimization and intravenous ondansetron in reducing the incidence of hypotension after the induction of general anesthesia in adults presenting for elective non-cardiac, non-obstetric surgery.	5 years

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: 0068-23-MMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No