Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 8:50 PM
Study NCT ID:
NCT07421661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Epilepsy and Antiepileptic Drug Therapy on Gastric Motility and Emptying With Point-Of-Care Gastric Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of epilepsy on gastric emptying after following pre-surgical fasting guidelines.', 'timeFrame': '2-4 hours prior to surgical start time.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Impact of antiepileptic therapy on gastric emptying.', 'timeFrame': '2-4 hours prior to surgical start time.', 'description': '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 and corelating results with prescribed epileptic therapies of each participant.'}, {'measure': 'Impact of epilepsy treatment on type of stomach contents present after following pre-surgical fasting guidelines.', 'timeFrame': '2-4 hours prior to surgical start time.', 'description': '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 and qualitatively assessing these contents as solids, liquids, or thick liquids.'}, {'measure': 'Impact of epilepsy duration on gastric volume after following pre-surgical fasting guidelines.', 'timeFrame': '2-4 hours prior to surgical start time.', 'description': '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 and corelating results with the epilepsy duration of each participant.'}, {'measure': 'Impact of seizure frequency on gastric volume after following pre-surgical fasting guidelines.', 'timeFrame': '2-4 hours prior to surgical start time.', 'description': '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 and corelating results with seizure frequency of each participant.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['POCUS', 'Gastric Volume', 'Anesthesia', 'Epilepsy', 'Fasting Guidelines'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '15666259', 'type': 'BACKGROUND', 'citation': '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': '26728182', 'type': 'BACKGROUND', 'citation': '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': '34187756', 'type': 'BACKGROUND', 'citation': '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': '38344171', 'type': 'BACKGROUND', 'citation': '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': '33968483', 'type': 'BACKGROUND', 'citation': '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': '39543202', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Epilepsy is a neurological disorder characterized by abnormal synchronous activity producing recurrent and unpredictable interruption of brain function and is diagnosed after two unprovoked seizures occurring at least 24 h apart. The prevalence of epilepsy is estimated to be between 0.5-2.2% with an annual incidence of 0.06%. As a result, anesthesiologists are almost certain to encounter these epileptic patients for both neurosurgical and non-neurosurgical procedures.\n\nCurrently, perioperative fasting guidelines advocated for epileptics are the same as those for the general population with fasting of 6-8 hours for solid food and 1 hour for clear liquids with the assumption of normal gastric emptying to minimize aspiration risk to zero. However, increasing evidence is emerging that assumptions of normal gastric emptying in epileptics patients might not be totally accurate and these patients might have high residual gastric volume and increased risk of aspiration and regurgitation during anesthesia induction.\n\nThe bidirectional impact of epilepsy on the gastrointestinal system is increasingly being recognized as functional gut-brain axis is disrupted through neural (vagal and sympathetic nerves), endocrine (e.g., gut hormones like ghrelin and cholecystokinin), and immune (e.g., cytokine-mediated inflammation) pathways by abnormal central nervous system hyperexcitability, chronic stress, and medication effects. Moreover, inflammatory factor stimulation by seizures, releases catecholamines and acetylcholine, which affect cholinergic transmission of gut sympathetic postganglionic nerves and thus, inhibit gut motility and increase gut transit time. In addition, seizures also impair GABAergic inhibitory control of hypothalamic paraventricular nucleus neurons and produce massive release of glucocorticoids, leading to increased cerebral excitability, triggering of a gut immune-inflammatory response and ultimately, increasing gut barrier permeability and reduced motility.\n\nFurthermore, antiepileptic drugs (AEDs) have been associated with gastrointestinal side effects including gastric hypomotility and paresis. For instance, in a prospective study of 104 patients, two commonly used antiepileptics, carbamazepine and phenytoin, in overdosage, were associated with severe gastric hypomotility with gastric emptying half-times exceeding 120-300 minutes possibly due to anticholinergic properties, direct toxic effects on smooth muscle, or stress-induced autonomic dysregulation. Another antiepileptic drug, ethosuximide, is known to cause constipation and gastroparesis. Lamotrigine, an antiepileptic drug, has been shown in animal studies to cause gastroparesis by blocking L-type calcium channels, relaxing gastric smooth muscles and decreasing motility. Further, supporting evidence comes from a case report of severe gastroparesis involving a patient of refractory epilepsy on Lamotrigine and Vagal nerve stimulator, which required augmentation of VNS current settings for relief of gastroparesis.\n\nVagal nerve stimulation is an established therapeutic approach for managing drug-refractory epilepsy. Consequently, it can be inferred that some level of vagal nerve dysfunction may be present in individuals affected by drug-refractory epilepsy. As vagal parasympathetic efferents are key modulator of gastroduodenal motility by promoting peristalsis, any vagal nerve dysfunction is likely to disrupt normal gastrointestinal motility. In a study of healthy subjects, modulation of vagal tone via transcutaneous auricular VNS (taVNS) or deep slow breathing-enhanced antral contractions and increased the motility index, suggesting potential restorative effects on impaired motility. A similar effect of trans auricular vagal nerve stimulation on gastroduodenal motility was noted in healthy volunteers with increased gastric motility index and higher amplitude of peristaltic waves with high frequency stimulation, over low-frequency stimulation. Another factor influencing gastric motility in epileptics is the impact of ketogenic diets recommended for treatment of drug refractory epilepsy. Being high in fat and low in carbohydrates, ketogenic diets are likely to prolong gastric emptying and lowers the oesophageal sphincter tone and might be risk factor for aspiration during anesthesia induction despite adequate fasting time.\n\nDespite the obvious direct evidence and multiple extrapolatory insights from overdose studies, animal models, and healthy volunteer trials as explained above, there is a significant evidence gap. Prospective studies have not systematically evaluated preoperative gastric volumes in epilepsy patients, particularly in the perioperative settings. Gastric ultrasound remains an excellent noninvasive modality to determine the adequacy of fasting periods and to safely administer anesthesia while eliminating the risk of aspiration. Point-of-care ultrasound (POCUS) has emerged as a reliable, non-invasive bedside tool for assessing gastric content and volume qualitatively (e.g., empty, fluid, solid) and quantitatively (e.g., via antral cross-sectional area measurements), with validated formulas demonstrating high accuracy in predicting aspiration risk thresholds (\\>1.5 mL/kg).\n\nThis observational study aims to address this gap by measuring gastric volume and other surrogate markers of gastric emptying as described below in 30 consecutive epilepsy patients undergoing elective neurologic or non-neurologic surgery, aiming to determine if standard fasting protocols are adequate or if additional interventions (such as institution of liquid diet/prokinetics) are needed.\n\nInformed, written consent will be obtained prior to the start of surgery.\n\nPatients who provide consent to participate will have one gastric ultrasound performed in the preoperative preparation area. Each ultrasound will take approximately 5 minutes to perform and imaging 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:\n\n1. 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. Also, accuracy of gastric volume assessments is much higher in RLD position. To enhance consistency, surrounding structures will be identified and recorded in the following sequence: the stomach, left lobe of liver, pancreas, superior mesenteric artery, aorta, and inferior vena cava. Furthermore, if gastric POCUS reveals solids or thick liquids, patients will be labelled as full stomach and no further cross-sectional area (CSA) measurements will be attempted. However, if initial Gastric POCUS reveals clear fluids, CSA measurement will be done at the aortic level as measurements at the inferior vena cava (IVC) level yield false negatives and will include the full thickness of the gastric wall from serosa to serosa. The mean of three consecutive CSA measurements during the peristaltic contraction interval for the final analysis will be determined.\n2. Peristalsis: Frequency of contractions will be noted over a full 3-minute period.\n\nPatient demographics, age, biological sex, race, weight, height, BMI, comorbidities (e.g., Hypertension, Diabetes, Chronic Kidney Disease, etc.), and American Society of Anesthesiologists (ASA) status will be collected. Epilepsy characteristics as classified by the International League Against Epilepsy (ILAE) 2025 Guidelines, as well as record of anti-seizure medications (ASMs) (i.e., age at starting, duration of treatment, name, overdosage history, and history of drug refractory history) will be collected as well. Details regarding surgery (i.e., emergency/elective, type, fasting compliance), and pre-operative hemodynamics and investigations will also be collected. Finally, details regarding gastric ultrasound, including operator, time and date, probe, position, structures identified, gastric content, and cross-sectional area readings will be collected. A final gastric volume will be calculated from this data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with epilepsy who are scheduled for surgery where general anesthesia will be used.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of epilepsy (confirmed by history or medical records and classified as per 2025 ILAE classification for seizures).\n2. Scheduled for elective neurologic (e.g., epilepsy surgery) or non-neurologic surgery under anesthesia.\n3. 18 years of age or older.\n4. Adherence to standard fasting guidelines (verified by patient report).\n\nExclusion Criteria:\n\n1. Refusal/withdrawal of consent.\n2. Noncompliance with fasting guidelines.\n3. Pregnancy.\n4. Patients with continuous treatment on GLP/GIP 1 analogues without a washout period.\n5. Parkinsons patients with proven gastroparesis.\n6. Diabetic neuropathy with gastroparesis\n7. Patients on Prokinetic agents (Metoclopramide/ Erythromycin)\n8. Neuro muscular/ neurodegenerative disorders with gastroparesis.\n9. Uncontrolled hypothyroidism.\n10. Bowel obstruction'}, 'identificationModule': {'nctId': 'NCT07421661', 'briefTitle': 'Effect of Epilepsy and Antiepileptic Drug Therapy on Gastric Motility and Emptying With Point-Of-Care Gastric Ultrasound', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Effect of Epilepsy and Antiepileptic Drug Therapy on Gastric Motility and Emptying by Comparing Gastric Volume With Point-Of-Care Gastric Ultrasound in Epileptic Patients After Standard CAS/ASA Fasting Guidelines', 'orgStudyIdInfo': {'id': 'Epilepsy and GV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric Ultrasound', 'description': "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:\n\n1. 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.\n2. Peristalsis: Frequency of contractions will be noted over a full 3-minute period.", 'interventionNames': ['Procedure: Gastric Ultrasound']}], 'interventions': [{'name': 'Gastric Ultrasound', 'type': 'PROCEDURE', 'description': "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:\n\nGastric 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.\n\nPeristalsis: Frequency of contractions will be noted over a full 3-minute period.", 'armGroupLabels': ['Gastric Ultrasound']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sujoy Banik', 'role': 'CONTACT', 'email': 'Sujoy.banik@lhsc.on.ca', 'phone': '5196858500', 'phoneExt': '13546'}], 'overallOfficials': [{'name': 'Sujoy Banik', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Sciences Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist, Assistant Professor', 'investigatorFullName': 'Sujoy Banik', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}