Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 10:26 AM
Study NCT ID:
NCT04224532
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2020-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019586', 'term': 'Intracranial Hypertension'}, {'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2020-01-09', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Optic Nerve Sheath Diameter', 'timeFrame': 'Throughout the surgery', 'description': 'The change in intracranial pressure via optic nerve sheath diameter measurement during laparoscopic cholecystectomy among 6 time point.'}, {'measure': 'Change in regional cerebral oxygen saturation', 'timeFrame': 'Throughout the surgery', 'description': 'The change in regional cerebral oxygen saturation during laparoscopic cholecystectomy among 6 time point.'}], 'secondaryOutcomes': [{'measure': 'Perioperative Hemodynamic Parameters', 'timeFrame': 'Throughout the surgery', 'description': 'Mean arterial pressure in mmHg'}, {'measure': 'Perioperative Hemodynamic Parameters', 'timeFrame': 'Throughout the surgery', 'description': 'Heart rate beat per minute'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['optic nerve sheath diameter', 'intracranial pressure', 'laparoscopic cholecystectomy', 'pneumoperitoneum'], 'conditions': ['Intracranial Pressure Increase', 'Pneumoperitoneum']}, 'referencesModule': {'references': [{'pmid': '27956677', 'type': 'BACKGROUND', 'citation': 'Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.'}, {'pmid': '25899811', 'type': 'BACKGROUND', 'citation': 'Dip F, Nguyen D, Rosales A, Sasson M, Lo Menzo E, Szomstein S, Rosenthal R. Impact of controlled intraabdominal pressure on the optic nerve sheath diameter during laparoscopic procedures. Surg Endosc. 2016 Jan;30(1):44-9. doi: 10.1007/s00464-015-4159-0. Epub 2015 Apr 22.'}, {'pmid': '28918894', 'type': 'BACKGROUND', 'citation': 'Sahay N, Sharma S, Bhadani UK, Singh A, Sinha C, Sahay A, Ranjan A, Agarwal M. Effect of Pneumoperitoneum and Patient Positioning on Intracranial Pressures during Laparoscopy: A Prospective Comparative Study. J Minim Invasive Gynecol. 2018 Jan;25(1):147-152. doi: 10.1016/j.jmig.2017.07.031. Epub 2017 Sep 12.'}, {'pmid': '33089454', 'type': 'DERIVED', 'citation': 'Demirgan S, Ozcan FG, Gemici EK, Guneyli HC, Yavuz E, Gulcicek OB, Selcan A. Reverse Trendelenburg position applied prior to pneumoperitoneum prevents excessive increase in optic nerve sheath diameter in laparoscopic cholecystectomy: randomized controlled trial. J Clin Monit Comput. 2021 Feb;35(1):89-99. doi: 10.1007/s10877-020-00608-6. Epub 2020 Oct 21.'}]}, 'descriptionModule': {'briefSummary': 'Reverse Trendelenburg position has been shown to slightly reduce the intracranial pressure associated with pneumoperitoneum. However, there are no studies on the effect of the timing of reverse Trendelenburg position on intracranial pressure. This study will monitor the effect of reverse Trendelenburg position before or after pneumoperitoneum on intracranial pressure and regional cerebral oxygen saturation.', 'detailedDescription': 'The literature includes studies that investigate the relationship of pneumoperitoneum and different positions with intracranial pressure during laparoscopy. Reverse Trendelenburg position has been shown to slightly reduce the intracranial pressure associated with pneumoperitoneum. However, there are no studies on the effect of the timing of reverse Trendelenburg position on intracranial pressure. This study will monitor the effect of reverse Trendelenburg position before or after pneumoperitoneum on intracranial pressure and regional cerebral oxygen saturation. Ultrasound guided measurement of the optic nerve sheath diameter as a non-invasive method will be used for measurement. The investigators believe reverse Trendelenburg position before pneumoperitoneum may prevent undesired sudden increases in intracranial pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing laparoscopic cholecystectomy operation\n* Age between 18-65\n* ASA I-II\n* BMI ≤ 35\n\nExclusion Criteria:\n\n* Ophthalmologic disease and optic nerve pathology\n* Increased intracranial pressure\n* History of cerebrovascular disease'}, 'identificationModule': {'nctId': 'NCT04224532', 'briefTitle': 'The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bagcilar Training and Research Hospital'}, 'officialTitle': 'The Effect of Pneumoperitoneum Timing on Intracranial Pressure in Laparoscopic Cholecystectomy: Before or After Reverse Trendelenburg Position', 'orgStudyIdInfo': {'id': '2019.10.103.072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group P', 'description': 'Pneumoperitoneum is induced before reverse Trendelenburg position.', 'interventionNames': ['Procedure: Pneumoperitoneum Timing (Before Positioning)']}, {'type': 'EXPERIMENTAL', 'label': 'Group RT', 'description': 'Pneumoperitoneum is induced after reverse Trendelenburg position.', 'interventionNames': ['Procedure: Pneumoperitoneum Timing (After Positioning)']}], 'interventions': [{'name': 'Pneumoperitoneum Timing (Before Positioning)', 'type': 'PROCEDURE', 'description': 'Before Reverse Trendelenburg Position', 'armGroupLabels': ['Group P']}, {'name': 'Pneumoperitoneum Timing (After Positioning)', 'type': 'PROCEDURE', 'description': 'After Reverse Trendelenburg Position', 'armGroupLabels': ['Group RT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34200', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bagcilar Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Serdar Demirgan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bagcilar Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bagcilar Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}