Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT07290504
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gradual Versus Intermittent Release of Tourniquet Effect on MAP in Hypertensive Patients Undergoing Upper Limb Orthopedic Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'After completion of surgical procedure, tourniquet deflation will be performed by anesthesia technician into two ways according to the randomization number received in closed envelop with the patient file and blinded from the research anesthiologist: in gradual group (Ggroup) deflation by rate 50mmHg/ 30s untill complete release within 3 minutes .In intermittent group (Igroup) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release.The researcher anesthesiologist who collects data, including hemodynamics and labs will be separated from the upper limb, tourniquet device, and the technician by surgical curtain to ensure full blinding of the deflation technique.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After completion of surgical procedure,tourniquet deflation will be performed by anesthesia technician into two ways according to the randomization number received in closed envelop with the patient file and blinded from the research anesthiologist: in gradual group (Ggroup) deflation by rate 50mmHg/ 30s untill complete release within 3 minutes .In intermittent group (Igroup) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-12-12', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Arterial Pressure', 'timeFrame': '5 minutes', 'description': 'The decrease in MAP (more than 25% compared to baseline) 5 minues after deflation.'}], 'secondaryOutcomes': [{'measure': 'Acid base status', 'timeFrame': '5 minutes', 'description': 'Acid base status'}, {'measure': 'Lactate', 'timeFrame': '30 minutes', 'description': 'Lactate level'}, {'measure': 'Potassium level', 'timeFrame': '30 minutes', 'description': 'Potassium level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mean arterial pressure', 'Acid base', 'Tourniquet', 'Orthopedics', 'Hypertension'], 'conditions': ['Hemodynamics']}, 'descriptionModule': {'briefSummary': 'In this clinical trial, the authors will compare two tourniquet deflation techniques and their clinical implications on hemodynamics and acid base parameters in hypertensive orthopedic patients undergoing upper limb surgeries under general anesthesia.', 'detailedDescription': "General anesthesia will be induced using an injection of 1-1.5 mg/kg of propofol, 1-2 mic/kg of fentanyl, and 0.5 mg/kg of atracurium,with all doses to be titrated. An endotracheal tube will be inserted after 3 minutes of mask ventilation.\n\nAnesthesia will be maintained using isoflurane (1%) and atracurium at a dosage of 0.1mg\\\\kg every 20 minutes.\n\nAfter endotracheal intubation, the patients will be mechanically ventilated with a 50% oxygen-air mixture, utilizing a tidal volume of 8 mL/kg based on ideal body weight at an inspiratory rate of 10-14 breaths per minute. Adjustments will be made to ensure that the end-tidal CO2 partial pressure (ETCO2) between 35 and 40 mmHg, with peak airway pressure kept below 30 mmHg.\n\nThe surgeon will start limb elevation, exsanguinating of blood and applying a double- cuffed tourniquet(zimmer A.T.S.3000) at the middle of the arm over cotton padding,with pressure ranging 200 mmHg according to the patient's blood pressure (50mmHg above systolic blood pressure).\n\nAfter completion of surgical procedure,tourniquet deflation will be performed by anesthesia technician blinded to the study groups into two ways according to the randomization number received in closed envelop with the patient file and blinded from the research anesthiologist: in gradual group (G group) deflation by rate 50mmHg/ 30s untill complete release within 3 minutes .In intermittent group (I group) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release. If the surgery exceeded 2 hr, the intermittent technique for deflation will be used The researcher anesthesiologist who collects data, including hemodynamics and labs will be separated from the upper limb, tourniquet device, and the technician by surgical curtain to ensure full blinding of the deflation technique.\n\nA bolus of lidocaine 1.5 mg\\\\kg will be administered 10 minutes before tourniquet inflation will be used to attenuate the increase of blood pressure after tourniquet inflation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertensive patients (controlled on medical treatment more than three months)\n* Patients scheduled for upper limb orthopedic surgeries using a tourniquet for at least 30 min.\n* BMI from 18.5 to 29.9\n\nExclusion Criteria:\n\n* Patient refusal\n* ASA physical status \\> II\n* Multiple orthopedic surgeries\n* Emergency surgeries\n* Patient with relative contraindications for tourniquet use'}, 'identificationModule': {'nctId': 'NCT07290504', 'briefTitle': 'Gradual Versus Intermittent Release of Tourniquet Effect on MAP in Hypertensive Patients Undergoing Upper Limb Orthopedic Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'The Effect of Gradual Versus Intermittent Release of Tourniquet on Mean Arterial Blood Pressure in Hypertensive Patients Undergoing Upper Limb Orthopedic Surgeries: A Blinded Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'N-77-2024/MSc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G group', 'description': 'Gradual group (G group) deflation by rate 50mmHg/ 30s until complete release within 3 minutes', 'interventionNames': ['Device: Tourniquet deflation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'I group', 'description': 'Intermittent group (I group) complete deflation will occur for 10 seconds, then reinflated for 50 seconds, repeating this cycle three times until complete release.', 'interventionNames': ['Device: Tourniquet deflation']}], 'interventions': [{'name': 'Tourniquet deflation', 'type': 'DEVICE', 'description': 'Tourniquet deflation technique', 'armGroupLabels': ['G group', 'I group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Khaled Sarhan, MD', 'role': 'CONTACT', 'email': 'khaled.sarhan@kasralainy.edu.eg', 'phone': '+201020067816'}], 'facility': 'Cairo university hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Khaled Sarhan, MD', 'role': 'CONTACT', 'email': 'khaled.sarhan@kasralainy.edu.eg', 'phone': '+201020067816'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator, Associate professor of anesthesia, Cairo university', 'investigatorFullName': 'Khaled Abdelfattah Abdallah Sarhan', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}