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Clinical Trials/NCT05784350
NCT05784350
Not yet recruiting
Not Applicable

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

Meir Medical Center1 site in 1 country150 target enrollmentAugust 1, 2025

Overview

Phase
Not Applicable
Intervention
fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone
Conditions
Intra-operative Hypotension
Sponsor
Meir Medical Center
Enrollment
150
Locations
1
Primary Endpoint
Efficacy of preoperative IVC-guided fluid optimization and intravenous ondansetron in reducing the incidence of hypotension after the induction of general anesthesia
Status
Not yet recruiting
Last Updated
11 months ago

Overview

Brief Summary

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?

Registry
clinicaltrials.gov
Start Date
August 1, 2025
End Date
May 1, 2028
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

sara dichtwald

Dr

Meir Medical Center

Eligibility Criteria

Inclusion Criteria

  • Elective, non-cardiac, non-obstetric surgery under general anesthesia
  • American Society of Anesthesiologists physical status classification I - III

Exclusion Criteria

  • MAP below 60 mmhg prior to the induction of general anesthesia.
  • Patients treated with angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB) on the day of surgery.
  • Patients with heart failure with ejection fraction (EF) \< 40%.
  • Patients with documented acute or chronic renal failure.
  • Patients with hepatic failure.
  • Patients with neuraxial (spinal/epidural) anesthesia performed before induction of general anesthesia.
  • Patients with suspected difficult airway.
  • Patients with documented allergy to Ondansetron or prolonged QT-syndrome.

Arms & Interventions

Intravenous fluid bolus

Intervention: fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone

Intravenous Ondansetron

Intervention: fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone

Outcomes

Primary Outcomes

Efficacy of preoperative IVC-guided fluid optimization and intravenous ondansetron in reducing the incidence of hypotension after the induction of general anesthesia

Time Frame: 5 years

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.

Study Sites (1)

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