Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT06081933
Status:
UNKNOWN
Last Update Posted:
2023-10-13
First Post:
2022-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of Endoscopic Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-07', 'studyFirstSubmitDate': '2022-12-11', 'studyFirstSubmitQcDate': '2023-10-07', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improving quality of the operative field', 'timeFrame': '24 hours postoperative', 'description': 'Patients\' satisfaction will be measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.'}], 'secondaryOutcomes': [{'measure': 'Heart rate will be evaluated', 'timeFrame': 'every 5 min till the end of procedure', 'description': 'Heart rate will be recorded at baseline and every 5 min till the end of procedure'}, {'measure': 'Mean arterial blood pressure will be evaluated.', 'timeFrame': 'every 5 min till the end of procedure', 'description': 'Mean arterial blood pressure will be recorded at baseline and every 5 min till the end of procedure'}, {'measure': 'Pain score will be evaluated.', 'timeFrame': '24 hour postoperatively', 'description': 'Pain score will be evaluated measured with Numerical rating scale The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable'}, {'measure': 'Adverse reactions of hemostatic stuffing after FESS will be evaluated.', 'timeFrame': '24 hour postoperatively', 'description': '1=no swelling, can tolerate; 2= swelling, can barely tolerate; 3= swelling, cannot tolerate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexmedetomidine', 'Functional Endoscopic Sinus']}, 'descriptionModule': {'briefSummary': 'compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving quality of the operative field in Functional endoscopic sinus surgery', 'detailedDescription': "Functional endoscopic sinus surgery is a well-established therapeutic option for intractable CRS and other indications. Functional endoscopic sinus surgery is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid leakage and the duration of surgery increase. Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications.\n\nDexmedetomidine is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes dexmedetomidine primarily sedative and anxiolytic.The elimination half-life of dexmedetomidine (t1/2b) is 2 h and the redistribution half-life (t1/2a) is 6 min, and this short half-life makes it an ideal drug for intravenous titration.\n\nIntranasal Dexmedetomidine is convenient, effective, and noninvasive and also has useful analgesic and sedative effects in surgical procedures. Cheung's research has shown that intranasal Dexmedetomidine 1 and 1.5 micro/kg in surgical procedures produced significant sedation and less postoperative pain. Several previous research were determined the effect of intranasal dexmedetomidine in several clinical evaluations"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients underwent Functional Endoscopic Sinus Surgery\n* American Society of Anesthesiologists (ASA) physical status classification I or II\n\nExclusion Criteria:\n\n* Patients with a body mass index \\> 30 kg/m2 existing or recent significant disease\n* contraindications to the use of dexmedetomidine\n* history or presence of a significant disease significant cardiovascular disease risk factors\n* significant coronary artery disease or any known genetic predisposition\n* history of any kind of drug allergy\n* drug abuse\n* psychological or other emotional problems\n* special diet or lifestyle\n* clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening\n* known systemic disease requiring the use of anticoagulants, patients with a history of previous Functional Endoscopic Sinus Surgery'}, 'identificationModule': {'nctId': 'NCT06081933', 'briefTitle': 'Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of Endoscopic Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of the Operative Field in Functional Endoscopic Sinus Surgery: A Randomized Triple-Blind Trial', 'orgStudyIdInfo': {'id': 'MKSU-50-9-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intranasal dexmedetomidine', 'description': 'Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline', 'interventionNames': ['Drug: intranasal dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'intravenous dexmedetomidine', 'description': 'patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.', 'interventionNames': ['Drug: intravenous dexmedetomidine']}], 'interventions': [{'name': 'intranasal dexmedetomidine', 'type': 'DRUG', 'description': 'Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline', 'armGroupLabels': ['intranasal dexmedetomidine']}, {'name': 'intravenous dexmedetomidine', 'type': 'DRUG', 'description': 'patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.', 'armGroupLabels': ['intravenous dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Kafr ash Shaykh', 'state': 'Kafr El-Shaikh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammad F Algyar, MD', 'role': 'CONTACT', 'email': 'mohammad.algaiar@med.kfs.edu.eg', 'phone': '00201111645345', 'phoneExt': '047'}, {'name': 'Kamal Ebeid, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mohammad Fouad Algyar', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Mohammad F Algyar, MD', 'role': 'CONTACT', 'email': 'mohammad.algaiar@med.kfs.edu.eg', 'phone': '00201111645345', 'phoneExt': '047'}], 'overallOfficials': [{'name': 'Kamal Ebeid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Otorhinolaryngology, Faculty of medicine, Tanta University, Egypt'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After one year', 'ipdSharing': 'YES', 'description': 'The data will be available upon reasonable request from the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine', 'investigatorFullName': 'Mohamed Fouad Algyar', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}