Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT05738135
Status:
COMPLETED
Last Update Posted:
2023-08-29
First Post:
2023-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aminophylline on Recovery in Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-26', 'studyFirstSubmitDate': '2023-02-11', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to extubation', 'timeFrame': 'Two hours after discontinuation of anesthetics', 'description': 'Extubation time, defined as the interval between the discontinuation of anesthetics to safe tracheal extubation.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative heart rate', 'timeFrame': 'Intraoperative period', 'description': 'Heart rate will be recorded preoperatively (baseline), after loading dose of dexmedetomidine, after intubation, every 5 minutes during the study drug infusion, then every 15 minutes until end of surgery.'}, {'measure': 'Intraoperative mean arterial blood pressure', 'timeFrame': 'Intraoperative period', 'description': 'Mean arterial blood pressure will be recorded preoperatively (baseline), after loading dose of dexmedetomidine, after intubation, every 5 minutes during the study drug infusion, then every 15 minutes until end of surgery.'}, {'measure': 'Postoperative sedation score', 'timeFrame': '60 minutes after tracheal extubation', 'description': 'Postoperative sedation will be evaluated using the Ramsay sedation score as:\n\n1 = anxious, agitated, or restless 2= cooperative, oriented, and tranquil 3= responsive to commands 4= a sleep, but with brisk response to light, glabella tap, or loud auditory stimulus 5= a sleep, sluggish response to glabella tap, or auditory stimulus 6= a sleep, no response 6 is the highest sedation level Sedation score: will be measured at 15, 30, and 60 minutes after tracheal extubation.'}, {'measure': 'Time to discharge from post anesthesia care unit', 'timeFrame': 'Two hours after tracheal extubation.', 'description': 'Time needed to achieve modified Aldrete Score ≥9 will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aminophylline', 'Dexmedetomidine', 'Hemodynamics', 'Recovery', 'Functional Endoscopic Sinus Surgery'], 'conditions': ['Aminophylline', 'Dexmedetomidine', 'Functional Endoscopic Sinus Surgery']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the effect of intravenous aminophylline on hemodynamics and recovery of patients receiving dexmedetomidine infusion during functional endoscopic sinus surgery.', 'detailedDescription': 'Aminophylline is a nonselective adenosine receptor antagonist used for the treatment of asthma and chronic obstructive pulmonary disease. It has been used to antagonize the effects of anaesthetic and analgesic agents'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 to 50 years, have American society of anesthesiology (ASA) physical status I - II and scheduled for elective FESS under general anesthesia and receiving dexmedetomidine infusion for controlled hypotension during surgery.\n\nExclusion Criteria:\n\n1. Patients with central nervous system diseases, cardiovascular diseases, hypertension, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.\n2. Pregnancy or lactation.\n3. Patients with a history of allergy to aminophylline.\n4. Patients with recurrent sinus surgery, hypertension.'}, 'identificationModule': {'nctId': 'NCT05738135', 'briefTitle': 'Aminophylline on Recovery in Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effect of Intravenous Aminophylline on Hemodynamics and Recovery of Patients Undergoing Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '36264PR58/1/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aminophylline group', 'description': 'Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.', 'interventionNames': ['Drug: Aminophylline group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive 50 ml normal saline over 30 minutes.', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Aminophylline group', 'type': 'DRUG', 'description': 'Patients will receive 4 mg/kg aminophylline diluted in 50 ml normal saline over 30 minutes.', 'armGroupLabels': ['Aminophylline group']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'Patients will receive 50 ml normal saline over 30 minutes.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31528', 'city': 'Tanta', 'state': 'ElGharbiaa', 'country': 'Egypt', 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'after 6 mon from publication', 'ipdSharing': 'YES', 'description': 'The data will be available upon reasonable request from the corresponding after 6 mon from publication', 'accessCriteria': 'The data will be available upon reasonable request from the corresponding'}, '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'}}}}