Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-01 @ 10:59 PM
Study NCT ID:
NCT05940935
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000138', 'term': 'Acidosis'}], 'ancestors': [{'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-02', 'studyFirstSubmitDate': '2023-06-21', 'studyFirstSubmitQcDate': '2023-07-07', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative Metabolic Acidosis', 'timeFrame': 'Baseline', 'description': 'The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.'}, {'measure': 'Intraoperative Metabolic Acidosis', 'timeFrame': 'during the operation', 'description': 'The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.'}, {'measure': 'Postoperative Metabolic Acidosis', 'timeFrame': 'Day 1', 'description': 'The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antiepileptic Drugs', 'Metabolic Acidosis', 'Anesthesia Management', 'Craniotomy'], 'conditions': ['Metabolic Acidosis', 'Antiepileptic Drugs', 'Craniotomy', 'Anesthesia Management']}, 'descriptionModule': {'briefSummary': 'The relationship of developing metabolic acidosis with antiepleptic drugs in craniotomy operations', 'detailedDescription': 'Metabolic acidosis is a life-threatening complication in the perioperative, intraoperative and postoperative period. It can cause decreased cardiac output, electrolyte imbalance, surgical bleeding and neurological complications, even coma and death in surgical patients.\n\nTopiramate and zonisamide are sulfonamide derivative compounds used in the treatment of epilepsy. It has been shown in studies that both drugs have a strong inhibition of carbonic anhydrase enzyme. Recent case reports suggest that both drugs may cause metabolic acidosis by lowering serum bicarbonate levels in some patients.\n\nAim in this study is to determine the relationship between preoperative, intraoperative and postoperative metabolic acidosis and to emphasize the importance of anesthesia management in patients who have undergone craniotomy and use antiepileptic drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent craniotomy and intracranial surgery at Trakya University Medical Faculty Hospital and used antiepileptic drugs were included in the study as a retrospective file review. The files of 35 patients who met the study criteria were reviewed retrospectively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing intracranial surgery with craniotomy and using antiepileptic drugs\n* ASA I-III\n* Patients undergoing elective surgery\n\nExclusion Criteria:\n\n* Patients with a surgical procedure time of more than 5 hours\n* Patients who received more than 2 units of blood transfusion during the operation\n* Patients taking other drugs that can cause metabolic acidosis\n* Patients with diabetes mellitus, diabetes insipidus, hepatic or renal disease'}, 'identificationModule': {'nctId': 'NCT05940935', 'briefTitle': 'The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': 'The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations; Does Topiramat or Zonisamide Cause Metabolic Acidosis?', 'orgStudyIdInfo': {'id': 'TÜTF-GOBAEK 2023/210'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients who have used Zonisamide or Topiramate', 'interventionNames': ['Procedure: Arterial Blood Gas Base Deficit']}, {'label': 'Group 2', 'description': 'Patients who have used Lacosamide', 'interventionNames': ['Procedure: Arterial Blood Gas Base Deficit']}, {'label': 'Group 3', 'description': 'Patients who have used Carbamazepine', 'interventionNames': ['Procedure: Arterial Blood Gas Base Deficit']}, {'label': 'Group 4', 'description': 'Patients who have used levetiracetam', 'interventionNames': ['Procedure: Arterial Blood Gas Base Deficit']}], 'interventions': [{'name': 'Arterial Blood Gas Base Deficit', 'type': 'PROCEDURE', 'description': 'The base deficit values in the preoperative, intraoperative and postoperative blood gases taken from the patients and the presence and severity of metabolic acidosis were evaluated. Metabolic acidosis severity was defined by base deficit levels: mild from -3 to -5, moderate from -5 to -10, and severe metabolic acidosis below -10.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22030', 'city': 'Edirne', 'state': 'Centrum', 'country': 'Turkey (Türkiye)', 'facility': 'Trakya University', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}], 'overallOfficials': [{'name': 'SEVTAP HEKİMOĞLU ŞAHİN, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trakya University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of anesthesiology and reanimation, Principal Investigator, Resident Doctor', 'investigatorFullName': 'Onur Kucuk', 'investigatorAffiliation': 'Trakya University'}}}}