Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-06 @ 10:49 PM
Study NCT ID:
NCT07062367
Status:
RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sevoflurane With or Without Intravenous Lidocaine Infusion Versus Propofol Anesthesia on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optic nerve sheath diameter', 'timeFrame': 'After extubating the endotracheal tube (up to one hour)', 'description': 'Optic nerve sheath diameter of both eyes is expressed in millimeters and will be assessed at times of: T0; baseline before induction, T1; after insertion of endotracheal tube, T2; just before pneumoperitoneum (PP), T3;30 minutes after PP and Trendelenburg position (TP),T4; 60 minutes after PP and TP,T5; Five minutes after disinflation of PP and T6;after extubating the endotracheal tube.'}], 'secondaryOutcomes': [{'measure': 'Cerebral oxygenation', 'timeFrame': 'After extubating the endotracheal tube (up to one hour)', 'description': 'Cerebral oxygenation of both hemispheres by near-infrared spectroscopy (NIRS). normal values 60-70% and will be assessed at times of: T0; baseline before induction, T1; after insertion of endotracheal tube, T2; just before pneumoperitoneum (PP), T3;30 minutes after PP and Trendelenburg position (TP), T4; 60 minutes after PP and TP, T5; Five minutes after disinflation of PP and T6; after extubating the endotracheal tube.'}, {'measure': 'Cognitive function', 'timeFrame': '4 hours postoperatively', 'description': 'Cognitive function by standardized mini mental state examination (SMMSE) preoperative, and 4hours postoperatively.'}, {'measure': 'Incidence of postoperative complications', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of postoperative complications such as hypotension, bradycardia, postoperative nausea and vomiting (PONV), and headache will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sevoflurane', 'Lidocaine', 'Propofol', 'Intracranial Pressure', 'Cerebral Oxygenation', 'Laparoscopic Hysterectomy']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the effects of different anesthetic modalities \\[sevoflurane with or without intraoperative lidocaine infusion and Propofol total intravenous anesthesia (TIVA)\\] on intracranial pressure (ICP) and cerebral oxygenation assessed by non-invasive methods during laparoscopic hysterectomy (LH).', 'detailedDescription': 'Laparoscopic hysterectomy (LH) requires a Trendelenburg position (TP) and the creation of an artificial pneumoperitoneum (PP) by carbon dioxide insufflation.\n\nVarious studies were done to evaluate the effects of different anesthesia techniques on intracranial pressure (ICP) during LH, and most of these studies revealed that propofol total intravenous anesthesia (TIVA) was superior to inhaled anesthesia regarding reduction of ICP (ONSD).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females scheduled for laparoscopic hysterectomy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age from 18 to 65 years.\n* American Society of Anesthesiologists (ASA) physical status I and Ⅱ.\n* Body mass index (BMI) ≤35.\n* Females scheduled for laparoscopic hysterectomy.\n\nExclusion Criteria:\n\n* Patients' refusal to participate in the study.\n* Hypersensitivity and allergy to drugs of the study.\n* Contraindication for optic nerve sheath diameter assessment. E.g., patient with pre-existing ophthalmic diseases, a history of ophthalmic surgery\n* Any central nervous system or cardiovascular disease, severe hepatic or renal impairment\n* Intraoperative circumstances, such as inability to perform optic nerve sheath diameter or conversion to open surgery\n* If peak inspiratory pressure (PIP) exceeds 35."}, 'identificationModule': {'nctId': 'NCT07062367', 'briefTitle': 'Sevoflurane With or Without Intravenous Lidocaine Infusion Versus Propofol Anesthesia on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effect of Sevoflurane With or Without Intravenous Lidocaine Infusion Versus Propofol Anesthesia on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Hysterectomy: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '36265MD329/12/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol group', 'description': "Patients' anesthesia will be maintained by manually adjusted propofol infusion at a rate of 100-250 mic/kg/min for bispectral index (BIS) maintained between 40-60.", 'interventionNames': ['Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'Sevoflurane plus lidocaine infusion group', 'description': 'Sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60 plus intravenous lidocaine infusion given as 2mg /kg IV bolus before induction then intraoperative infusion by a rate of 2 mg/kg/h until the end of surgery.', 'interventionNames': ['Drug: Sevoflurane plus lidocaine infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Sevoflurane group', 'description': 'Patients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60.', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': "Patients' anesthesia will be maintained by manually adjusted propofol infusion at a rate of 100-250 mic/kg/min for bispectral index (BIS) maintained between 40-60.", 'armGroupLabels': ['Propofol group']}, {'name': 'Sevoflurane plus lidocaine infusion', 'type': 'DRUG', 'description': 'Sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60 plus intravenous lidocaine infusion given as 2mg /kg IV bolus before induction then intraoperative infusion by a rate of 2 mg/kg/h until the end of surgery.', 'armGroupLabels': ['Sevoflurane plus lidocaine infusion group']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'Patients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60.', 'armGroupLabels': ['Sevoflurane group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Eman A Elrefaey, Master', 'role': 'CONTACT', 'email': 'eman.elrefaey@med.tanta.edu.eg', 'phone': '00201008031402'}, {'name': 'Hesham M Marof, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ashraf E Elzeftawy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohammed S Abdelghafar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Osama M Rehab, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Eman A Elrefaey, Master', 'role': 'CONTACT', 'email': 'eman.elrefaey@med.tanta.edu.eg', 'phone': '00201008031402'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Eman Ali Abd-Elsamea Elrefaey', 'investigatorAffiliation': 'Tanta University'}}}}