Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT06024733
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-13
First Post:
2023-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Anesthesia by Targeted Controlled Infusion Versus Inhalational Anesthesia on the Surgical Stress Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The level of the stress response by serum level of insulin-like growth factors', 'timeFrame': 'Intraoperative and 24hours after surgery', 'description': 'The serum level of insulin-like growth factors will be measured at preoperative, intraoperative after one hour of intubation, at the end of surgery and after extubation, and transfer to the intensive care unit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Intravenous Anesthesia', 'Inhalational Anesthesia', 'Surgical Stress Response', 'Target-controlled Infusion']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effect of total Intravenous anesthesia Target-controlled infusion (TIVA-TCI) with inhalational anesthesia on stress response.', 'detailedDescription': 'Target-controlled infusion (TCI) techniques have been used to induce and maintain general anesthesia or to provide computer-assisted personalized sedation. Target-controlled infusion (TCI) systems are computer-assisted IV infusion pumps that use pharmacokinetic and pharmacodynamic mathematical modeling to maintain a user-designated target concentration at an effect site (typically the brain).\n\nThe clinician enters a desired target concentration for an anesthetic or another agent. The computer calculates the amount of the agent required to achieve the target concentration at the effect site and directs an infusion pump to deliver the calculated boluses or infusions. Therefore, TIVA-TCI allows a more stable hemodynamic profile during surgery, prevents long-acting opioid-induced accumulation and allows rapid recovery from general anesthesia.\n\nTotal intravenous anaesthesia (TIVA) regimen with Propofol is a useful anaesthetic technique, effectively controlling responses to tracheal intubation and intense surgical stimulation, while avoiding Inhalational anaesthetics and allowing rapid emergence from anaesthesia .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients subjected to lower abdominal cancer surgery.\n2. Patients of both sexes\n3. body mass index \\< 35 kg/m2.\n4. Age from 18 to 60 years.\n5. ASA, I-II.\n\nExclusion Criteria:\n\n1. Patients with a history of severe cardiovascular or respiratory disease.\n2. Severe hepatic, renal, or neurological diseases.'}, 'identificationModule': {'nctId': 'NCT06024733', 'briefTitle': 'Intravenous Anesthesia by Targeted Controlled Infusion Versus Inhalational Anesthesia on the Surgical Stress Response', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Total Intravenous Anesthesia by Targeted Controlled Infusion on Surgical Stress Response Compared to Inhalational Anesthesia', 'orgStudyIdInfo': {'id': '525'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'inhalational', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Target Controlled Infusion', 'interventionNames': ['Drug: Target Controlled Infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Target Controlled Infusion and lidocaine', 'interventionNames': ['Drug: Target Controlled Infusion and lidocaine']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['group 1'], 'description': 'patient recieve propofol for induction and sevoflurane for maintenance', 'armGroupLabels': ['inhalational']}, {'name': 'Target Controlled Infusion', 'type': 'DRUG', 'otherNames': ['GROUP 2'], 'description': 'target controlled infusion of propofol', 'armGroupLabels': ['Target Controlled Infusion']}, {'name': 'Target Controlled Infusion and lidocaine', 'type': 'DRUG', 'otherNames': ['GROUP3'], 'description': 'patients will receive total intravenous anesthesia with propofol Target Controlled Infusion. At the induction of anesthesia, the patients will receive a bolus of lidocaine 1% 1.5 mg/kg and a continuous infusion of lidocaine 1% 2 mg/kg/h will be associated throughout the procedure.', 'armGroupLabels': ['Target Controlled Infusion and lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'for one year after the end of study', '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': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of Anesthesia, ICU and pain Relief South Egypt Cancer Institute- Assiut University', 'investigatorFullName': 'Noha Ali Galal', 'investigatorAffiliation': 'Assiut University'}}}}