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

• Sponsor: Meir Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05784350
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Intra-operative Hypotension	Drug: fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension: A Randomized Controlled Trial
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: May 1, 2028
• Anticipated Study Completion Date: May 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intravenous fluid bolus	Drug: 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.
Active Comparator: Intravenous Ondansetron	Drug: 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.
No Intervention: No intervention

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meir Medical Center	Kfar Saba		Israel

Sponsors and Collaborators

• Meir Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: sara dichtwald, Dr, Meir Medical Center
• ClinicalTrials.gov Identifier: NCT05784350
• Other Study ID Numbers: 0068-23-MMC
• First Posted: Mar 24, 2023
• Last Update Posted: Mar 24, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypotension

Study Results

No Results Posted as of Mar 24, 2023