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

Not Applicable

Not yet recruiting

• Conditions: Intra-operative Hypotension
• Interventions: Drug: fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone

• Registration Number: NCT05784350
• Lead Sponsor: Meir Medical Center

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Study Start: 2024-12-01
• Primary Completion: 2028-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous Ondansetron	fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone	-
Intravenous fluid bolus	fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel