Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-01 @ 7:47 AM
Study NCT ID:
NCT06639659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sphenopalatine Block vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059387', 'term': 'Sphenopalatine Ganglion Block'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D001340', 'term': 'Autonomic Nerve Block'}, {'id': 'D009407', 'term': 'Nerve Block'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 69}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2024-09-26', 'studyFirstSubmitQcDate': '2024-10-10', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain using VAS scale.', 'timeFrame': '24hours', 'description': 'Pain will be assessed based on VAS scale from (1-10), as 1 is the least pain and 10 is the maximal pain possible at 2, 4, 6, 12 and 24h after surgery.'}, {'measure': 'Surgical field using Average Category Scale (ACS).', 'timeFrame': '5hours', 'description': 'Done by asking the surgeon about amount of bleeding on a scale of (0-5) as 0= no bleeding and 5= sever bleeding, every 15 min interval till the end of surgery.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sphenopalatine Ganglion Nerve Block', 'Transnasal Endoscopic Pitutary Surgery']}, 'referencesModule': {'references': [{'pmid': '33199256', 'type': 'BACKGROUND', 'citation': 'Anthony Cometa M, Zasimovich Y, Smith CR. Percutaneous sphenopalatine ganglion block: an alternative to the transnasal approach. Int J Obstet Anesth. 2021 Feb;45:163-164. doi: 10.1016/j.ijoa.2020.10.002. Epub 2020 Oct 17. No abstract available.'}, {'pmid': '38262005', 'type': 'BACKGROUND', 'citation': 'Mantovani G, Sgarbanti L, Indaimo A, Cavallo MA, De Bonis P, Flacco ME, Scerrati A. Effects of a sphenopalatine ganglion block on postcraniotomy pain management: a randomized, double-blind, clinical trial. Neurosurg Focus. 2023 Dec;55(6):E13. doi: 10.3171/2023.9.FOCUS23549.'}, {'pmid': '33456810', 'type': 'BACKGROUND', 'citation': 'Hutton M, Brull R, Macfarlane AJR. Regional anaesthesia and outcomes. BJA Educ. 2018 Feb;18(2):52-56. doi: 10.1016/j.bjae.2017.10.002. Epub 2017 Nov 27. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Improving pain and surgical field by using sphenopalatine ganglion block and dexmedetomidine in trans-nasal endoscopic pituitary surgery.', 'detailedDescription': 'Pituitary neoplasm is one of the most common sellar pathology. Trans-nasal endoscopic pituitary surgery (TEPS) evolved rapidly, almost replacing the craniotomy approach. TEPS, a surgical instrument, is primarily executed through a minimally invasive approach through the nostril to access a pituitary tumor.\n\nThat is why the anesthetic plan must ensure the best possible surgical field visualization and the most adequate analgesia.\n\nMultimodal anesthesia including regional and general anesthesia are obtained to optimize surgical field by decreasing bleeding, reduce pain, promote rapid recovery and potential economic gains for the hospital.\n\nThe sphenopalatine ganglion block (SPGB) is considered one of the regional anesthetic techniques that is safe and easy anesthetic procedure used to control bleeding and for postoperative analgesia.\n\nDexmedetomidine (DEX) has become popular for induced hypotension. It is an α2-adrenoceptor agonist with a sympatholytic and analgesic effect. It provides a unique conscious sedation without respiratory depression. It is used effectively in optimizing surgical field through its hemodynamic stability effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: between 21-64 years old.\n* sex: males and females.\n* Body mass index: 35 kg/m2.\n* ASA Physical status: grade Ⅰ-Ⅱ.\n\nExclusion Criteria:\n\n* patients receiving beta blockers, anti-coagulants and antihypertensive medications also patients receiving clonidine or benzodiazepines, neuroleptics or antidepressants two weeks prior to the study.\n* Any contraindication for regional anesthesia e.g. coagulopathy, infection at site of block and hypersensitivity to any drug used in this study.\n* Patients who are known to be drug addict.'}, 'identificationModule': {'nctId': 'NCT06639659', 'briefTitle': 'Sphenopalatine Block vs Dexmedetomidine Infusion in Trans Nasal Endoscopic Pituitary Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Bilateral Supra-Zygomatic Sphenopalatine Ganglion Block Versus Dexmedetomidine for Relief of Postoperative Pain and Surgical Field Improvement in Trans-nasal Endoscopic Pituitary Surgery', 'orgStudyIdInfo': {'id': 'sphenopalatine block in TEPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group C (control group) (n=23) patients will be operated under general anesthesia.', 'interventionNames': ['Other: General Anesthesia (control group)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group SPGP (n=23) patients will receive ultrasound guided bilateral sphenopalatine block', 'interventionNames': ['Procedure: Sphenopalatine Ganglion Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group DEX (n=23) patients will receive dexmedetomidine drug.', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Sphenopalatine Ganglion Block', 'type': 'PROCEDURE', 'description': 'patients will receive ultrasound guided bilateral supra-zygomatic sphenopalatine ganglion block.', 'armGroupLabels': ['Group SPGP (n=23) patients will receive ultrasound guided bilateral sphenopalatine block']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'patients will receive 1 µg/kg dexmedetomidine within 10 minutes, followed by maintenance dose throughout the surgery.', 'armGroupLabels': ['Group DEX (n=23) patients will receive dexmedetomidine drug.']}, {'name': 'General Anesthesia (control group)', 'type': 'OTHER', 'description': 'patients will be operated under general anesthesia including routine protocol for these cases', 'armGroupLabels': ['Group C (control group) (n=23) patients will be operated under general anesthesia.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig Univesity Hospital', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}