Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT05772260
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wobble of Systolic Arterial Pressure (SAP) during surgery', 'timeFrame': 'During the intraoperative period, from the enterance to the operating room to the emergence of anesthesia', 'description': 'Wobble of SAP will be calculated according to the following formula. Performance Error (PE (%)) = (measured SAP-reference SAP) × 100/reference SAP Median performance error (MDPE (%)) = median {PEi, i = 1, 2, 3…, N} Median absolute performance error (MDAPE (%)) = median {\\|PE\\| , i = 1, 2, 3…, N} (N, number of measured SAP) Wobble (%) = median{\\|MDPE - PEi\\|, i = 1, 2, 3…, N}(N, number of measured PE) reference SAP = 120 mmHg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Achalasia']}, 'referencesModule': {'references': [{'pmid': '32504156', 'type': 'BACKGROUND', 'citation': 'Saugel B, Vokuhl C, Pinnschmidt HO, Rosch T, Petzoldt M, Loser B. Cardiovascular dynamics during peroral endoscopic myotomy for esophageal achalasia: a prospective observational study using non-invasive finger cuff-derived pulse wave analysis. J Clin Monit Comput. 2021 Aug;35(4):827-834. doi: 10.1007/s10877-020-00541-8. Epub 2020 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study aims to investigate the association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy under general anesthesia in achalasia patients. Per-oral endoscopic myotomy is known as the effective treatment for achalasia patients. During per-oral endoscopic myotomy, capnoperitoneum, capnomediastinum, and systemic CO2 accumulation can potentially impair hemodynamics. Moreover, it has been suggested that achalasia is associated with autonomic dysfunction. We hypothesized that patients with autonomic dysfunstion would esperience more hemodynamic instability during per-oral endoscopic myotomy compared with patients without autonomic dysfunction. In this prospective observational study, the autonomic function test will be performed before surgery, and advanced hemodynamic parameters will be recorded using EV1000 clinical platform (Edwards Lifesciences, USA) during surgery. The association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who are scheduled to undergo per-oral endoscopic myotomy in Gangnam Severance Hospital will be eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are scheduled to undergo per-oral endoscopic myotomy in Gangnam Severance Hospital\n2. Patients aged ≥ 19 years\n\nExclusion Criteria:\n\n1. Patients who are hemodynamically unstable before surgery\n2. Patients in whom preoperative heart rate variability (HRV) test cannot be conducted\n3. Pregnant women of breastfeeding women\n4. Patients unable to read the informed consent form'}, 'identificationModule': {'nctId': 'NCT05772260', 'briefTitle': 'Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Effect of Autonomic Dysfunction on Hemodynamic Instability During Per-oral Endoscopic Myotomy in Achalasia Patients: a Prospective Observational Study', 'orgStudyIdInfo': {'id': '3-2022-0491'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with autonomic dysfunction', 'description': 'Achalasia patients who have autonomic dysfunction in the heart rate variability test (HRV test) performed preoperatively.', 'interventionNames': ['Procedure: Per-oral endoscopic myotomy']}, {'label': 'Patients with normal autonomic function', 'description': 'Achalasia patients without autonomic dysfunction in the heart rate variability test (HRV test) performed preoperatively.', 'interventionNames': ['Procedure: Per-oral endoscopic myotomy']}], 'interventions': [{'name': 'Per-oral endoscopic myotomy', 'type': 'PROCEDURE', 'otherNames': ['general anesthesia'], 'description': 'Per-oral endoscopic myotomy will be performed under general anesthesia. Per-oral endoscopic myotomy will be performed according to the standard care.\n\nGeneral anesthesia will be conducted according to the standard care in our institution, and standardized as follows.\n\n* Monitoring: ECG, SpO2, noninvasive blood pressure, invasive blood pressure monitoring via radial artery cannulation, advanced hemodynamic monitoring (including cardiac output, cardiac index) uisng EV1000 clinical platform (Edwards Lifesciences, USA), anesthetic depth monitoring by SedLine Sedation monitor (Masimo corporation).\n* Anesthetic induction: Target controlled infusion (TCI) of Remifentanil (target 3.0 ng/mL), propofol 2 mg/kg IV, rocuronium 0.8 mg/kg IV\n* Anesthetic maintence: sevoflurane 0.9 age corrected MAC and remifentanil TCI (target range 1.0-4.0 ng/mL)', 'armGroupLabels': ['Patients with autonomic dysfunction', 'Patients with normal autonomic function']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sunkyung Park', 'role': 'CONTACT', 'email': 'gsirb@yuhs.ac', 'phone': '82-2-2019-4601'}], 'facility': 'GangnamSeverance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'sunkyung Park', 'role': 'CONTACT', 'email': 'gsirb@yuhs.ac', 'phone': '82-2-2019-4601'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dong Woo Han', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}