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

Primary Purpose

Intra-operative Hypotension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intra-operative Hypotension

Eligibility Criteria

19 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age > 18 Elective, non-cardiac, non-obstetric surgery under general anesthesia American Society of Anesthesiologists physical status classification I - III Exclusion Criteria: 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. -

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Intravenous fluid bolus

Intravenous Ondansetron

No intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2023
Last Updated
October 18, 2023
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05784350
Brief Title
Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension
Official Title
Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2028 (Anticipated)
Study Completion Date
May 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-operative Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous fluid bolus
Arm Type
Active Comparator
Arm Title
Intravenous Ondansetron
Arm Type
Active Comparator
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
fluid boluses guided by IVC diameter via US/administration of pre-operative IV Odansetrone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of preoperative IVC-guided fluid optimization and intravenous ondansetron in reducing the incidence of hypotension after the induction of general anesthesia
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 Elective, non-cardiac, non-obstetric surgery under general anesthesia American Society of Anesthesiologists physical status classification I - III Exclusion Criteria: 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Dichtwald, Dr
Phone
972-9-7472133
Ext
1
Email
sara.dichtwald@clalit.org.il
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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