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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Aug 1, 2025 to Feb 1, 2027
    • Interventions: fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone (Drug) to fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone (Drug)
    • Eligibility criteria expanded, about 11 words
  2. Start date: Dec 1, 2024 to Aug 1, 2025v4
  3. Start date: Dec 1, 2023 to Dec 1, 2024v3
  4. Start date: May 1, 2023 to Dec 1, 2023v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT05784350
Lead Sponsor Meir Medical Center
Conditions
(from sponsor)		 Intra-operative Hypotension
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov