Evaluation of Erythromycin Lactobionate on Gastric Emptying in Ischemic Stroke Patients Undergoing Mechanical Thrombectomy

The primary objective of this study is to evaluate the efficacy of **erythromycin** IVSE in decreasing the antral surface area during emergency mechanical thrombectomy procedures in patients with ischemic stroke. This is clinically relevant as it addresses the management of gastric contents, which can impact the safety and effectiveness of interventional neuroradiology procedures.

Secondary objectives include:

• Estimating the percentage of full and empty stomach situations upon arrival in the interventional neuroradiology unit.
• Estimating the proportion of patients with a 30% reduction in antral surface area post-revascularization.
• Comparing the effectiveness of gastric emptying with erythromycin administration to the control group.
• Describing the influence of antral ultrasound on anesthesia protocols.
• Determining the impact of patient positioning on antral surface measurement.
• Estimating gastric volume from antral surface measurements in the lateral decubitus position.
• Evaluating the impact of erythromycin on patient prognosis during revascularization procedures and hospital stay.

The clinical trial involves participants who are **patients** presenting to the neuroradiological emergency room with an ischemic stroke and requiring interventional neuroradiology for stroke. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. Participants are required to have significant gastric contents as determined by ultrasound measurements prior to the procedure. The trial does not involve a vulnerable population. The sponsor has not provided the total number of participants. Selection criteria include major patients with ischemic stroke who require emergency interventional neuroradiology for mechanical thrombectomy, regardless of the anesthetic procedure used. Informed consent must be obtained from the patient or a relative, or through an emergency procedure, and participants must be affiliated with a health insurance plan. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of **erythromycin lactobionate** administered via intravenous infusion in reducing the antral surface area during emergency mechanical thrombectomy procedures in patients with ischemic stroke. This study is a randomized, double-blind, controlled trial, ensuring that neither the participants nor the investigators are aware of the treatment allocations, thereby minimizing bias. The trial is expected to commence on November 15, 2023, and conclude by November 30, 2024, with the participant involvement lasting for a maximum of one day, given the nature of the emergency procedure.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit where eligibility is confirmed based on specific criteria, including the presence of significant gastric contents as determined by an antral ultrasound. The primary endpoint is the percentage reduction in antral surface area between the initial ultrasound and the one conducted post-thrombectomy. Secondary endpoints include the frequency and proportion of patients with a 30% reduction in antral surface area, and the influence of ultrasound findings on anesthetic management strategies.

Follow-up visits are not applicable due to the acute nature of the intervention. The end-of-study visit coincides with the completion of the thrombectomy procedure, where final assessments are conducted. Participants may be terminated early from the study if they do not meet the inclusion criteria, if they withdraw consent, or if any adverse events related to the administration of erythromycin occur. The trial aims to provide valuable insights into the potential benefits of erythromycin in enhancing gastric emptying during critical stroke interventions.

The clinical trial involves the administration of **erythromycin lactobionate**, a chemical compound used as the experimental medication. This substance is provided in the form of a **powder for solution for injection**. The administration route is via **intravenous infusion**, ensuring direct delivery into the bloodstream. The dosage is set at a maximum of 250 mg per day, with the total dose not exceeding 250 mg. The treatment period is limited to a single day, aligning with the study's objective to evaluate the efficacy of erythromycin in reducing antral surface area in patients undergoing emergency mechanical thrombectomy for ischemic stroke.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified in the study protocol. The focus remains solely on the administration of erythromycin lactobionate. Participant compliance with the dosing schedule is monitored to ensure adherence to the protocol, although specific compliance monitoring methods are not detailed in the available data.

The efficacy of erythromycin lactobionate in the clinical trial will be assessed by evaluating its impact on gastric emptying in patients undergoing emergency mechanical thrombectomy for ischemic stroke. The primary endpoint for efficacy assessment is the percentage reduction in antral surface area, measured by antral gastric ultrasound, between the initial ultrasound and the ultrasound conducted after the thrombectomy procedure in the neuroradiology unit. Secondary endpoints include the frequency and proportion of patients with an ultrasonographic antral surface area greater than 340 mm² at the start and less than 340 mm² at the end of the procedure, as well as the proportion of patients achieving a 30% reduction in antral surface area during the procedure.

Additional secondary endpoints involve the influence of ultrasound findings on anesthetic management strategies, such as changes in anesthetic strategy, decisions regarding orotracheal intubation, and nasogastric tube placement. The trial will also assess the frequency and proportion of complications typically encountered during thrombectomy procedures, including hypotension, desaturation, and difficult airway management. Furthermore, the study will evaluate the use of oxygen therapy, post-procedure transfer to intensive care, and the occurrence of adverse events related to erythromycin administration during the hospital stay. These efficacy parameters will be collected and analyzed using validated ultrasonographic techniques and patient-reported outcomes at specified timepoints throughout the trial.