Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 12:27 AM
Study NCT ID:
NCT05705050
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2023-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-24', 'studyFirstSubmitDate': '2023-01-21', 'studyFirstSubmitQcDate': '2023-01-21', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of pain', 'timeFrame': 'In post anesthesia care unit (PACU)', 'description': 'Visual analogue score (VAS) score: will be measured on arrival to PACU, at 30 minutes, 1 hour, 2 hour, 6, 12 and 24 hour after surgery.'}], 'secondaryOutcomes': [{'measure': 'Intensity of pain', 'timeFrame': '24 hour after surgery', 'description': 'Visual analogue score (VAS) score: will be measured on arrival to PACU, at 30 minutes, 1 hour, 2 hour, 6, 12 and 24 hour after surgery.'}, {'measure': 'Total amount of opioid dose', 'timeFrame': '24 hour after surgery', 'description': 'If Patients reported VAS score more than 3, they will receive intravenous 0.5 mg /kg pethidine. All patients will be observed in PACU for at least 2 hour and in the ward on the day of surgery for confirming any side effects or complications.'}, {'measure': 'The incidence of postoperative adverse reactions', 'timeFrame': '24 hour after surgery', 'description': 'the incidence of adverse reactions, such as arrhythmia, postoperative nausea and vomiting (PONV) and postoperative lightheadedness will be recorded in both groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aminophylline', 'Postoperative Pain', 'Ureterocopic Lithotripsy'], 'conditions': ['Aminophylline', 'Pain', 'Ureterocopic Lithotripsy']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the effect of intraoperative systemic aminophylline infusion on pain intensity in patients undergoing ureteroscopic lithotripsy surgeries with ureteric stent placement at the end of the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 to 50 years\n* American society of anesthesiology (ASA) physical status I - II\n* Body mass index (BMI) less than 30.0 kg/m2\n* Scheduled for ureteroscopic lithotripsy surgery with D-J ureteric stent placement at the end of procedure\n* Under general anesthesia.\n\nExclusion Criteria:\n\n1. Patients with central nervous system diseases, cardiovascular diseases, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.\n2. Pregnancy or lactation.\n3. Patients with a history of allergy to aminophylline.\n4. Coffee consumption (more than 2 cups/day)\n5. Patients with opioid addiction or patients treated with B agonists, tranquilizers, or antidepressants.\n6. Short procedures less than 30 minutes or procedures not requiring D-J stent placement.'}, 'identificationModule': {'nctId': 'NCT05705050', 'briefTitle': 'Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effect of Intraoperative Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy Surgeries', 'orgStudyIdInfo': {'id': '36264PR19/1/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aminophylline group', 'description': 'Patients will receive 4 mg/kg aminophylline diluted in 100 ml normal saline over 20 minutes after induction of anesthesia and positioning of patients in lithotomy position.', 'interventionNames': ['Drug: Aminophylline group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Aminophylline group', 'type': 'DRUG', 'description': 'Patients will receive 4 mg/kg aminophylline diluted in 100 ml normal saline over 20 minutes after induction of anesthesia and positioning of patients in lithotomy position.', 'armGroupLabels': ['Aminophylline group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'ElGharbiaa', 'country': 'Egypt', 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'The data will be available 6 months after publication', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author', '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': 'Lecturer of Anesthesiology, Intensive Care and Pain Medicine', 'investigatorFullName': 'Osama Rehab', 'investigatorAffiliation': 'Tanta University'}}}}