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

NCT ID: NCT05784350

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intravenous fluid bolus

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

-

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

sara dichtwald

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

Central Contacts

Sara Dichtwald, Dr

Role: CONTACT

sara.dichtwald@clalit.org.il

972-9-7472133 ext. 1

Other Identifiers

0068-23-MMC

Identifier Type: -

Identifier Source: org_study_id