Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-03 @ 10:28 PM
Study NCT ID:
NCT05726968
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2022-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Patients will be randomly allocated to one of the 3 groups by sealed closed envelop technique'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The purpose of this study is to determine the least sufficient dose of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg required for day-case lower abdominal and urologic surgeries , fewer adverse effects, faster recovery time, and shorter stay in post anesthesia care unit (PACU) in the geriatric patient population, as a previous study has investigated hyperbaric prilocaine (30 mg) when combined with fentanyl (20 µg) for a day-case perianal surgery, achieving a spinal anaesthesia with a mean sensory level of T9'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-13', 'studyFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2023-02-04', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of motor Block in hours', 'timeFrame': 'Through Study Completion,an average of 1day', 'description': "The primary outcome measure will be duration of motor Block in minutes, defined as the duration between intrathecal drug injection and time to unassisted ambulation or Bromage's score = 0 (no motor block)."}], 'secondaryOutcomes': [{'measure': 'Onset of sensory block in minutes', 'timeFrame': 'Through Study Completion,an average of 1day', 'description': 'Onset of sensory block, defined as the duration between intrathecal drug injection and complete absence of skin sensation to the pinprick test at T10 dermatome level in minutes.'}, {'measure': 'Onset of motor block in minutes', 'timeFrame': 'Through Study Completion,an average of 1day', 'description': "Onset of motor block, defined as the duration between intrathecal drug injection and reaching a Bromage's score ≥ 2 in minutes."}, {'measure': 'Highest dermatomal level of sensory block.', 'timeFrame': 'Through Study Completion,an average of 1day', 'description': 'Highest dermatomal level of sensory block.'}, {'measure': 'Time to reach to highest sensory block in minutes.', 'timeFrame': 'Through study completion,an average of 1day', 'description': 'Time to reach to highest sensory block in minutes.'}, {'measure': 'Motor block at the time of reaching highest sensory block.', 'timeFrame': 'through study completion,an average of 1day', 'description': 'Motor block at the time of reaching highest sensory block.'}, {'measure': 'Full regression of sensory block', 'timeFrame': 'Through Study Completion,an average of 1day', 'description': 'Full regression of sensory block, defined as the duration between intrathecal drug injection and regression to the S2 dermatome in minutes.'}, {'measure': 'Duration of PACU stay', 'timeFrame': 'Through Study Completion,an average of 1day', 'description': 'Duration of Post Anesthesia Care Unit stay in minutes.'}, {'measure': 'The incidence of adverse effects', 'timeFrame': 'Through Study Completion,an average of 1day', 'description': 'The incidence of adverse effects like hypotension, bradycardia, apnea, nausea, shivering, pruritus, block failure and pain during the operation. Failure to achieve a block level of T10 or additional analgesia request will be considered as block failure. Hypotension will be defined as a systolic blood pressure of \\< 90 mmHg or a decrease in mean arterial pressure of more than 20% from baseline preoperative value and bradycardia will be defined as heart rate \\< 50 beat/min.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl']}, 'descriptionModule': {'briefSummary': 'To compare the effects of using different doses of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg in patients scheduled for a day-case lower abdominal and urologic surgery in the geriatric patient population.', 'detailedDescription': '* To evaluate the safety and effectiveness of spinal anaesthesia with hyperbaric Prilocaine 2% in a reduced dose (30mg) in combination with Fentanyl (25µg) in day-case lower abdominal and urologic surgeries in the geriatric population.\n* To compare between three different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.\n* To estimate the duration of stay in PACU and hospital stay with different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age (65 - 80)\n* ASA I - III\n* Both genders.\n* Height (1.60-1.90) m.\n* BMI (18.5-40) kg m-2\n* Scheduled for elective day-case lower abdominal or urologic procedures \\< 90 minutes in duration under spinal anesthesia.\n* Type of surgery: Inguinal, femoral and incisional herniorrhaphies, bilateral varicocelectomies, hydrocelectomy, lymph node biopsies and mass excision biopsies, TURP surgery, Cystoscopies, ureteroscopy, bladder stone extraction, DJ insertion.\n\nExclusion Criteria:\n\n* Patients requiring general anesthesia.\n* Operations requiring sensory block above T10.\n* Known or suspected coagulopathy (international normalised ratio \\> 1.4), thrombocytopenia (platelet count \\< 100,000).\n* Known peripheral neuropathy, neurological deficits or skeletal deformities.\n* Known allergy to prilocaine.\n* Infection at site of injection.\n* Patients' refusal to sign informed consent.\n* Patients 'not meet inclusion criteria."}, 'identificationModule': {'nctId': 'NCT05726968', 'briefTitle': 'A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.', 'orgStudyIdInfo': {'id': 'MD-248-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '● Group P1 (N 15)', 'description': 'Patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).', 'interventionNames': ['Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany']}, {'type': 'ACTIVE_COMPARATOR', 'label': '● Group P2 (N 15)', 'description': 'Patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).', 'interventionNames': ['Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany']}, {'type': 'ACTIVE_COMPARATOR', 'label': '● Group P3 (N 15)', 'description': 'patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml)', 'interventionNames': ['Drug: Pilocaine 2% (1.5 ml) and 25 ug fentany']}], 'interventions': [{'name': 'Pilocaine 2% (1.5 ml) and 25 ug fentany', 'type': 'DRUG', 'otherNames': ['Pilocaine 2%(2 ml) and 25 ug fentany', 'Pilocaine 2%(2.5 ml) and 25 ug fentany'], 'description': 'Patients will be randomly allocated into the study groups according to the list of random numbers. The study groups will be as follows:\n\n* Group P1 (N 15): patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).\n* Group P2 (N 15): patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).\n* Group P3 (N 15): patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).', 'armGroupLabels': ['● Group P1 (N 15)', '● Group P2 (N 15)', '● Group P3 (N 15)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11451', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ahmed Abdalla Mohamed', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Till Study Ending'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norhan Abdel Aleem Ali', 'class': 'UNKNOWN'}, {'name': 'Hagar Hassanein Refaee', 'class': 'UNKNOWN'}, {'name': 'Ahmed Abdullah Fathi Mohamed Almadawi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University', 'investigatorFullName': 'Ahmed Abdalla', 'investigatorAffiliation': 'Cairo University'}}}}