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

NCT05784350 | Not Yet Recruiting

• 1 other identifier: 0068-23-MMC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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?

Conditions

Intra-operative Hypotension

Outcome Measures

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.

  5 years

Study Arms (3)

Intravenous fluid bolus

ACTIVE COMPARATOR

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

Intravenous Ondansetron

ACTIVE COMPARATOR

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

No intervention

NO INTERVENTION

Interventions

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.

Intravenous Ondansetron; Intravenous fluid bolus

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Elective, non-cardiac, non-obstetric surgery under general anesthesia
• American Society of Anesthesiologists physical status classification I - III

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Central Study Contacts

Sara Dichtwald, Dr

CONTACT

972-9-7472133; sara.dichtwald@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)