Effect of Epilepsy and Antiepileptic Drug Therapy on Gastric Motility and Emptying With Point-Of-Care Gastric Ultrasound

NCT07421661 | Not Yet Recruiting

• 1 other identifier: Epilepsy and GV
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

People with epilepsy often need surgery, but it is not fully known whether their stomachs empty food and liquids at the same rate as people without epilepsy. Some seizure medications, special diets, and nerve changes related to epilepsy may slow digestion, which could increase the risk of stomach contents entering the lungs during anesthesia. The purpose of this study is to find out whether people with epilepsy still have food or liquid in their stomachs before surgery, even after following standard fasting rules. To do this, researchers will use a simple bedside ultrasound scan of the stomach before surgery. The scan takes only a few minutes and does not involve needles, radiation, or pain and will determine what food and/or liquid may be present in the stomach before surgery. About 30 adults with epilepsy scheduled for surgery will take part in this study. The results of this study may help to inform whether or not the surgical fasting guidelines for epilepsy patients need to be modified. This is a prospective, observational study that will take place at University Hospital, London Health Sciences Centre.

Conditions

Epilepsy

Keywords

POCUS; Gastric Volume; Anesthesia; Epilepsy; Fasting Guidelines

Outcome Measures

Primary Outcomes (1)

• Impact of epilepsy on gastric emptying after following pre-surgical fasting guidelines.

  This will be measured by conducting preoperative point of care gastric ultrasounds on epilepsy patients, to determine the contents of their stomach, who arrived for surgery after following the surgical preparation fasting guidelines.

  2-4 hours prior to surgical start time.

Secondary Outcomes (4)

• Impact of antiepileptic therapy on gastric emptying.

  2-4 hours prior to surgical start time.

• Impact of epilepsy treatment on type of stomach contents present after following pre-surgical fasting guidelines.

  2-4 hours prior to surgical start time.

• Impact of epilepsy duration on gastric volume after following pre-surgical fasting guidelines.

  2-4 hours prior to surgical start time.

• Impact of seizure frequency on gastric volume after following pre-surgical fasting guidelines.

  2-4 hours prior to surgical start time.

Study Arms (1)

Gastric Ultrasound

Patients who provide consent to participate will have one gastric ultrasound performed in the preoperative preparation area. Each ultrasound will will be done in both the supine position and right lateral decubitus (RLD) position. Ultrasound gel will be applied to the patient's abdomen and the ultrasound probe will be placed on the abdomen midline just below the sternum using a curvilinear probe (usually 2-5 MHz). The following imaging and assessment will be performed: 1. Gastric cross-sectional area: It will be assessed both in supine and Right Lateral Decubitus position as a full stomach (presence of solids or thick liquids) can be confirmed in the supine position but accuracy is significantly higher in RLD. 2. Peristalsis: Frequency of contractions will be noted over a full 3-minute period.

Procedure: Gastric Ultrasound

Interventions

Gastric Ultrasound PROCEDURE

Patients who provide consent to participate will have one gastric ultrasound performed in the preoperative preparation area. Each ultrasound will will be done in both the supine position and right lateral decubitus (RLD) position. Ultrasound gel will be applied to the patient's abdomen and the ultrasound probe will be placed on the abdomen midline just below the sternum using a curvilinear probe (usually 2-5 MHz). The following imaging and assessment will be performed: Gastric cross-sectional area: It will be assessed both in supine and Right Lateral Decubitus position as a full stomach (presence of solids or thick liquids) can be confirmed in the supine position but accuracy is significantly higher in RLD. Peristalsis: Frequency of contractions will be noted over a full 3-minute period.

Gastric Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with epilepsy who are scheduled for surgery where general anesthesia will be used.

You may qualify if:

• Diagnosis of epilepsy (confirmed by history or medical records and classified as per 2025 ILAE classification for seizures).
• Scheduled for elective neurologic (e.g., epilepsy surgery) or non-neurologic surgery under anesthesia.
• years of age or older.
• Adherence to standard fasting guidelines (verified by patient report).

You may not qualify if:

• Refusal/withdrawal of consent.
• Noncompliance with fasting guidelines.
• Pregnancy.
• Patients with continuous treatment on GLP/GIP 1 analogues without a washout period.
• Parkinsons patients with proven gastroparesis.
• Diabetic neuropathy with gastroparesis
• Patients on Prokinetic agents (Metoclopramide/ Erythromycin)
• Neuro muscular/ neurodegenerative disorders with gastroparesis.
• Uncontrolled hypothyroidism.
• Bowel obstruction

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Related Publications (6)

• Adams BK, Mann MD, Aboo A, Isaacs S, Evans A. Prolonged gastric emptying half-time and gastric hypomotility after drug overdose. Am J Emerg Med. 2004 Nov;22(7):548-54. doi: 10.1016/j.ajem.2004.08.017.

  PMID: 15666259 BACKGROUND

• Frokjaer JB, Bergmann S, Brock C, Madzak A, Farmer AD, Ellrich J, Drewes AM. Modulation of vagal tone enhances gastroduodenal motility and reduces somatic pain sensitivity. Neurogastroenterol Motil. 2016 Apr;28(4):592-8. doi: 10.1111/nmo.12760. Epub 2016 Jan 4.

  PMID: 26728182 BACKGROUND

• Steidel K, Krause K, Menzler K, Strzelczyk A, Immisch I, Fuest S, Gorny I, Mross P, Hakel L, Schmidt L, Timmermann L, Rosenow F, Bauer S, Knake S. Transcutaneous auricular vagus nerve stimulation influences gastric motility: A randomized, double-blind trial in healthy individuals. Brain Stimul. 2021 Sep-Oct;14(5):1126-1132. doi: 10.1016/j.brs.2021.06.006. Epub 2021 Jun 27.

  PMID: 34187756 BACKGROUND

• Zhu H, Wang W, Li Y. The interplay between microbiota and brain-gut axis in epilepsy treatment. Front Pharmacol. 2024 Jan 26;15:1276551. doi: 10.3389/fphar.2024.1276551. eCollection 2024.

  PMID: 38344171 BACKGROUND

• Dougherty MI, Zarroli K, Kapur J. Improvement in Symptomatic Gastroparesis With Increased Vagal Nerve Stimulation. Neurol Clin Pract. 2021 Feb;11(1):e18-e19. doi: 10.1212/CPJ.0000000000000775. No abstract available.

  PMID: 33968483 BACKGROUND

• Nassar MF, Shata MO, Awadallah SM, Youssef MA, Ibrahim HE. Impact of L-carnitine supplementation on gastric emptying and bowel function in pediatric ketogenic diet therapy: a clinical trial. Sci Rep. 2024 Nov 15;14(1):28099. doi: 10.1038/s41598-024-78779-4.

  PMID: 39543202 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sujoy Banik

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sujoy Banik

CONTACT

5196858500; Sujoy.banik@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Assistant Professor

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share