Trials / Not Yet Recruiting
Not Yet RecruitingNCT05784350
Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension
Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension: A Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Meir Medical Center · Academic / Other
- Sex
- All
- Age
- 19 Years – 99 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2028-05-01
- Completion
- 2028-05-01
- First posted
- 2023-03-24
- Last updated
- 2025-05-08
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT05784350. Inclusion in this directory is not an endorsement.