Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT05897151
Status:
UNKNOWN
Last Update Posted:
2023-06-13
First Post:
2023-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-10', 'studyFirstSubmitDate': '2023-05-07', 'studyFirstSubmitQcDate': '2023-06-08', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': '28 Days postoperative', 'description': "Patients' mortality during the first 28 day after surgery"}], 'secondaryOutcomes': [{'measure': 'Changes of Heart Rate', 'timeFrame': 'UP to 2 hours postoperative', 'description': 'Heart Rate: pre induction (base line), just after induction then at\n\n1min, 5min,10min, 15min, 30min,1 hour after induction, at the end of the surgery and 2 hours postoperative'}, {'measure': 'Changes of Invasive Blood Pressure', 'timeFrame': 'UP to 2 hours postoperative', 'description': 'Invasive Blood Pressure: pre induction, just after induction then at\n\n1min, 5min,10min ,15min, 30min ,1 hour after induction , at the end of the surgery and 2 hours postoperative'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Continuous Spinal Anesthesia', 'General Anesthesia']}, 'descriptionModule': {'briefSummary': 'The anesthetic efficacy and safety of continuous spinal anesthesia and comparing it with general anesthesia technique in sepsis diagnosed patient.', 'detailedDescription': 'Hemodynamic instability due to high block largely limits the use of conventional dose spinal anesthesia in high-risk septic patients. Hypotension is more common, and also more hazardous, in septic patients, as they may have decreased physiological reserve and compromised blood supply to various vital organs. A smaller dose of local anesthetic reduces the severity and incidence of hypotension during spinal anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 21 years old\n* American Society of Anesthesiologists (III, IV) diagnosed with sepsis (Sequential Organ Failure Assessment (SOFA) score ≥ 7)\n* Hemodynamically stable and not on vasopressor due to lower limb pathology candidate for spinal anesthesia to drain source of infection.\n\nExclusion Criteria:\n\n* Patients with known hypersensitivity to local anesthesia.\n* Infection at the site of injection.\n* Coagulopathy.\n* Septic shock.\n* Increase of intracranial pressure.\n* Severe deformity of the spinal column.'}, 'identificationModule': {'nctId': 'NCT05897151', 'briefTitle': 'Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study Between Continuous Spinal Anesthesia Versus General Anesthesia in Patients With Sepsis', 'orgStudyIdInfo': {'id': '35987/10/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous spinal anesthesia', 'description': 'Preservative free 0.5% Hyperbaric bupivacaine (AstraZeneca) 5mg + 25mcg fentanyl for the initial dose will be followed by top up doses of 2.5 mg boluses of 0.5% Hyperbaric bupivacaine every 10 minutes until the desired block height is obtained considering patient hemodynamics. Norepinephrine starting dose 0.01 micg/kg/min will be ready for both groups if needed (main arterial pressure \\< 70 or main arterial pressure decreased more than 20% of preoperative value). The infusion will be through a wide bore Intravenous line. The dose will be titrated up or down according to the patient hemodynamics.', 'interventionNames': ['Drug: Continuous spinal anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General anesthesia', 'description': 'After establishing of ASA monitoring, a wide bore cannula (18Gague) will be inserted. Induction will be done by fentanyl (2 mcg/kg), titrating dose. of propofol according to patient hemodynamic response and atracurium (0.5 mg/kg) to facilitate tracheal intubation maintaining End tidal Co2 between 30-40 mmHg.', 'interventionNames': ['Drug: General anesthesia']}], 'interventions': [{'name': 'Continuous spinal anesthesia', 'type': 'DRUG', 'description': 'Preservative free 0.5% Hyperbaric bupivacaine (AstraZeneca) 5mg + 25mcg fentanyl for the initial dose will be followed by top up doses of 2.5 mg boluses of 0.5% Hyperbaric bupivacaine every 10 minutes until the desired block height is obtained considering patient hemodynamics.\n\nNorepinephrine starting. dose 0.01 micg/kg/min will be ready for both groups if needed (Mean arterial pressure \\< 70 or Mean arterial pressure decreased more than 20% of preoperative value). The infusion will be through a wide bore Intravenous line. The dose will be titrated up or down according to the patient hemodynamics.', 'armGroupLabels': ['Continuous spinal anesthesia']}, {'name': 'General anesthesia', 'type': 'DRUG', 'description': 'After establishing of ASA monitoring, a wide bore cannula (18 G) will be inserted. Induction will be done by fentanyl ( 2 mcg/kg ) , titrating dose of propofol according to patient hemodynamic response and atracurium ( 0.5 mg/kg ) to facilitate tracheal intubation maintaining End tidal Co2 between 30-40 mmHg.', 'armGroupLabels': ['General anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31511', 'city': 'Tanta', 'state': 'Elgharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mahmoud R Ahmed, MBBCh', 'role': 'CONTACT', 'email': 'mahmoud162104_pg@med.tanta.edu.eg', 'phone': '+20 102 432 0926'}], 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mahmoud R Ahmed, M.B.B.CH', 'role': 'CONTACT', 'email': 'mahmoud162104_pg@med.tanta.edu.eg', 'phone': '+20 102 432 0926'}, {'name': 'Mahmoud R Ahmed', 'role': 'CONTACT', 'email': 'mahmoud162104_pg@med.tanta.edu.eg', 'phone': '+20 102 432 0926'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'From one year after study completion.', 'ipdSharing': 'YES', 'description': 'The data will be available upon reasonable request from the corresponding author from one year after study completion.', 'accessCriteria': 'The data will be available upon reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahmoud Rashad Ahmed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine', 'investigatorFullName': 'Mahmoud Rashad Ahmed', 'investigatorAffiliation': 'Tanta University'}}}}