Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT04309318
Status:
UNKNOWN
Last Update Posted:
2020-12-29
First Post:
2020-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Hemodynamic Changes Caused by Different Pneumoperitoneum Pressure Ranges (10-12 mmHg and 13- 15 mmHg ) on Cerebral Oxygenation (With a Non-invasive Technique, Near Infrared Spectroscopy (NIRS) ) in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-11-10', 'releaseDate': '2021-10-12'}], 'estimatedResultsFirstSubmitDate': '2021-10-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-26', 'studyFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigating the corelation between pneumoperitoneum pressure(mmHg) and brain oxygenation (with numeric NIRS value)', 'timeFrame': 'February 2020 - February 2021', 'description': 'Investigating the effects of different pneumoperitoneum pressure ranges (10-12 mmHg and 13-15 mmHg) on brain oxygenation with NIRS (according to baseline NIRS value )'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['laparoscopic cholecystectomy', 'Pneumoperitoneum', 'Near Infrared Spectroscopy (NIRS)'], 'conditions': ['Pneumoperitoneum']}, 'descriptionModule': {'briefSummary': 'The negative effects of pneumoperitoneum used in laparoscopic cholecystectomy on cerebral metabolism, intracranial pressure, cardiovascular (blood pressure, heart rate, venous return) and respiratory system are known.\n\nPneumoperitoneum formed with low (10 - 12 mmHg) intraabdominal pressure causes less fluctuations in hemodynamic and respiratory changes. Previous studies have shown that intraabdominal pressure increase is effective on cerebral metabolism, leading to increased intracranial pressure.\n\nThe aim of this study is to investigate the hemodynamic effects of two different pneumoperitoneum pressure ranges (10-12 mmHg and 13-15 mmHg) on cerebral oxygenation with using Near Infrared Spectroscopy (NIRS), which is is a non-invasive technique, in laparoscopic cholecystectomy surgeries.', 'detailedDescription': 'The negative effects of pneumoperitoneum used in laparoscopic cholecystectomy on cerebral metabolism, intracranial pressure, cardiovascular (blood pressure, heart rate, venous return) and respiratory system are known.It is thought that pneumoperitoneum causes hemodynamic changes in the body by increasing blood catecholamine, vasopressin and norepinephrine levels.Sensitivity to these hemodynamic changes has been shown to be higher rate in patients with advanced age, morbid obesity, and increased intracranial pressure, and it is emphasized in studies that more attention should be paid to pneumoperitoneum pressures used in laparoscopic procedures with these groups.\n\nIn laparoscopic cholecystectomy surgery, pneumoperitoneum pressures used for surgical field visualization may differ.As a consequences, these different pressures have different haemodynamic and intracranial effects.Studies have shown that high intraabdominal pressure values cause more hemodynamic fluctuations than low intraabdominal pressure values.Systemic side effects have been shown to be lower in operations with low pneumoperitoneum pressure; In relation to the concept of multiple compartment syndrome, it is thought that the relationships between intraabdominal, intrathoracic and intracranial compartments, and changes in one compartment may affect other compartments and cause negative physiological and hemodynamic results.\n\nThere are studies in the literature on the hemodynamic effects of different pneumoperitoneum pressures.In our literature searches, we could not find any study comparing the effects of hemodynamic changes caused by two different pneumoperitoneum pressures, which can be classified as low and high, on cerebral oxygenation.We aimed to contribute to the literature by investigating the effects of different pneumoperitoneum pressure ranges on brain oxygenation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for elective laparoscopic cholecystectomy between February 2020 and September 2020 at Karadeniz Technical University Faculty of Medicine Farabi Hospital under specified conditions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anaesthesiology (ASA) I-III,\n* 18-65 years old\n* under general anesthesia\n* elective laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* cerebrovascular diseases\n* uncontrolled diabetes\n* uncontrolled hypertension\n* coagulopathy\n* cirrhosis\n* peritonitis\n* asthma\n* respiratory diseases such as chronic obstructive pulmonary disease (COPD)\n* patients with morbid obesity\n* multiple organ failure\n* cases taken under emergency conditions\n* cases returned to open cholecystectomy'}, 'identificationModule': {'nctId': 'NCT04309318', 'briefTitle': 'Effects of Hemodynamic Changes Caused by Different Pneumoperitoneum Pressure Ranges (10-12 mmHg and 13- 15 mmHg ) on Cerebral Oxygenation (With a Non-invasive Technique, Near Infrared Spectroscopy (NIRS) ) in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Effects of Hemodynamic Changes Caused by Different Pneumoperitoneum Pressures on Cerebral Oxygenation in Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '2020/11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low pneumoperitoneum (10-12 mmHg) pressure range group', 'description': 'Patients who have elective laparoscopic cholecystectomy with 10-12 mmHg intra-abdominal pneumoperitoneum pressure', 'interventionNames': ['Procedure: Low pneumoperitoneum (10-12 mmHg) pressure range group']}, {'label': 'High pneumoperitoneum (13-15 mmHg) pressure range group', 'description': 'Patients who have elective laparoscopic cholecystectomy with 13-15 mmHg intra-abdominal pneumoperitoneum pressure', 'interventionNames': ['Procedure: High pneumoperitoneum (13-15 mmHg) pressure range group']}], 'interventions': [{'name': 'Low pneumoperitoneum (10-12 mmHg) pressure range group', 'type': 'PROCEDURE', 'description': 'Patients who have elective laparoscopic surgery with 10-12 mmHg intra-abdominal pneumoperitoneum pressure', 'armGroupLabels': ['Low pneumoperitoneum (10-12 mmHg) pressure range group']}, {'name': 'High pneumoperitoneum (13-15 mmHg) pressure range group', 'type': 'PROCEDURE', 'description': 'Patients who have elective laparoscopic surgery with 13-15 mmHg intra-abdominal pneumoperitoneum pressure', 'armGroupLabels': ['High pneumoperitoneum (13-15 mmHg) pressure range group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61080', 'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Karadeniz Technical University', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'SEDAT SAYLAN', 'investigatorAffiliation': 'Karadeniz Technical University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-10-12', 'type': 'RELEASE'}, {'date': '2021-11-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'SEDAT SAYLAN, Assistant Professor Doctor, Karadeniz Technical University'}}}}