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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-99
SponsorMeir Medical Center

About this 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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18

Elective, non-cardiac, non-obstetric surgery under general anesthesia

American Society of Anesthesiologists physical status classification I - III

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

    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.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Intravenous fluid bolusActive comparator 1 intervention
Group B: Intravenous OndansetronActive comparator 1 intervention
Group C: No interventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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