Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-07 @ 6:54 AM
Study NCT ID:
NCT06473194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This Study Assess Some Physiological Parameters, Blood Picture, and Hemodynamic Parameters, Blood Pressure, Respiratory Assess by SPO2, During Different Periods in Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D006339', 'term': 'Heart Rate'}, {'id': 'D000089382', 'term': 'Oxygen Saturation'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'describe techniques of laparoscopic procedures. 2. Discuss complications and assessments of patients who undergo laparoscopic procedures. 3. to assess liver function and hematological effects due to laparoscopic surgery 4. cardiovascular and respiratory squeal due to laparoscopic complication is minor compared to open surgery and can be managed rapidly.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2024-06-01', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood pressure.', 'timeFrame': 'during preoperative, 5 minute, intraoperative every five minute with post operative read after one hour', 'description': 'blood pressure in mmHg, pulse rate in beat per minute'}, {'measure': 'AST and ALT liver enzymes were measured, by blood samples taken intravenously in the perioperative period', 'timeFrame': '5 minute pre-operation and 5 minute postoperative', 'description': 'in unit/liter'}, {'measure': 'blood sugar, should measured and assessed with different groups', 'timeFrame': '5 minute during pre-operative and 15 minute post- operative period', 'description': 'blood sugar in mg/dl'}, {'measure': 'end-tidal Co2, measured and compared statistically with other parameter', 'timeFrame': 'perioperatively every 5 minute', 'description': 'End-tidal Co2 in CMH2O'}, {'measure': 'pulse rate measured continuously during intra-operative and compared with other hemodynamic parameter', 'timeFrame': '5 minute during preoperative, and continue every 5 minute in perioperatively', 'description': 'beat per minute (BPM)'}], 'secondaryOutcomes': [{'measure': 'measurement of body weight', 'timeFrame': 'measured preoperative period by 5 minute and post-operative during 15 minute', 'description': 'in Kg'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia Complication', 'Physiological Parameter']}, 'referencesModule': {'references': [{'pmid': '25558633', 'type': 'BACKGROUND', 'citation': 'Celep RB, Kahramanca S, Ozsoy M, Azili C, Cetinkunar S, Hasdemir AO, Guzel H, Ozgehan G, Colhan I, Kucukpinar TH. Effects of intraabdominal pressure on mean platelet volume during laparoscopic cholecystectomy. Turk J Med Sci. 2014;44(3):360-4. doi: 10.3906/sag-1304-23.'}, {'pmid': '30158037', 'type': 'BACKGROUND', 'citation': 'Bitkin A, Aydin M, Irkilata L, Keles M, Akgunes E, Ocak S, Atilla MK. Effect of Intra-abdominal Pressure Rise on Hematological Parameters in Laparoscopic Urologic Surgery. J Coll Physicians Surg Pak. 2018 Sep;28(9):699-702. doi: 10.29271/jcpsp.2018.09.699.'}, {'pmid': '26855512', 'type': 'BACKGROUND', 'citation': 'Sen MC, Turkyilmaz Z, Sonmez K, Karabulut R, Kaya Z, Yenicesu I, Gursel T, Basaklar AC. The Effect of Carbon Dioxide Insufflation Applied at Different Pressures and Periods on Thrombotic Factors. Indian J Hematol Blood Transfus. 2016 Mar;32(1):87-91. doi: 10.1007/s12288-015-0517-2. Epub 2015 Feb 15.'}, {'pmid': '16186960', 'type': 'BACKGROUND', 'citation': 'Crema E, Ribeiro EN, Hial AM, Alves Junior JT, Pastore R, Silva AA. Evaluation of the response of cortisol, corticotropin and blood platelets kinetics after laparoscopic and open cholecystectomy. Acta Cir Bras. 2005 Sep-Oct;20(5):364-7. doi: 10.1590/s0102-86502005000500005. Epub 2005 Sep 5.'}, {'pmid': '15863986', 'type': 'BACKGROUND', 'citation': 'Hasukic S, Kosuta D, Muminhodzic K. Comparison of postoperative hepatic function between laparoscopic and open cholecystectomy. Med Princ Pract. 2005 May-Jun;14(3):147-50. doi: 10.1159/000084630.'}]}, 'descriptionModule': {'briefSummary': "Laparoscopic surgery is widely used now. These benefits included many items, e.g. reducing post-operative pain, cosmetic the result was improved, and the patient also had more satisfaction for the patient and reduced hospital stay. This surgery involved insufflation of gas into the peritoneal cavity, producing pneumoperitoneum, and causing an increase in intra-abdominal pressure. The raised intraabdominal pressure of the pneumoperitoneum, the patient's position alteration, and the absorption of carbon dioxide into the abdomen have a direct effect on causing a change in physiology, especially in the cardiovascular and respiratory systems. These effects, as well as a direct effect of gas insufflation, may have significant effects on the patient especially if the patient has a comorbidity or is elderly.", 'detailedDescription': 'The objective of this study was to assess the technique used in laparoscopic surgery and their associated complications, including some hematological parameters, (these include blood pictures and liver enzymes), respiratory, (including the inspired and expired tidal volume, oxygen saturation, airway pressure, plateau pressure, and use of PEEP) cardiovascular system (including the systolic, diastolic, and mean blood pressure, heart rate)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. elective abdominal surgery\n2. a healthy, fit person\n3. use of general anesthetics\n4. use of pneumoperitoneum and CO2 insufflation\n\nExclusion Criteria:\n\n1. emergency condition\n2. patient with cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT06473194', 'acronym': 'laparoscopy', 'briefTitle': 'This Study Assess Some Physiological Parameters, Blood Picture, and Hemodynamic Parameters, Blood Pressure, Respiratory Assess by SPO2, During Different Periods in Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tunis University'}, 'officialTitle': 'Physiological and Biochemical Effects of Laparoscopic Anesthesia and Surgery', 'orgStudyIdInfo': {'id': 'physiological measurement'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'age , gender', 'description': 'group according to age and according to gender', 'interventionNames': ['Procedure: general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum']}], 'interventions': [{'name': 'general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum', 'type': 'PROCEDURE', 'otherNames': ['monitoring in anesthesia to asses hemodynamic parameter includes blood pressure, pulse rate, and SPO2, compared with biochemical blood sugar, liver enzyme, respiratory alteration by end-tidal CO2'], 'description': 'this research will involve the selection of elective cases with ASA class I or II and assessment of patients with respiratory cardiovascular parameters and hematology perioperative', 'armGroupLabels': ['age , gender']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohammed Ab. younis, PHD', 'role': 'CONTACT', 'email': 'mohammedhameed330@gmail.com', 'phone': '009647801870904'}, {'name': 'wissem H. HMIDA, PROFF.', 'role': 'CONTACT', 'email': 'hmidawissem@gmail.com', 'phone': '+21698452331'}], 'overallOfficials': [{'name': 'hussam Mu. Kareem, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ministry of Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'after approval and acceptance these data would be available soon'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohammed Abdulhameed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mohammed Abdulhameed', 'investigatorAffiliation': 'Tunis University'}}}}