Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:26 AM
Study NCT ID:
NCT07425834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cold Dissection vs Electrocautry on TCR in Septoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-14', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of TCR', 'timeFrame': '3 hours from induction', 'description': 'Defined as a decrease in heart rate \\>20% from baseline during surgery'}], 'secondaryOutcomes': [{'measure': 'Magnitude of heart rate reduction', 'timeFrame': '3 hours from induction', 'description': 'reduction of heart rate less than 50 beats/min'}, {'measure': 'Intraoperative hypotension or arrhythmias', 'timeFrame': '3 hours from induction', 'description': 'decrease mean blood pressure less than 60mmgh'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trigeminal cardiac reflex', 'Cold Dissection', 'Electrocautery'], 'conditions': ['Septoplasty Surgeries']}, 'referencesModule': {'references': [{'pmid': '27812317', 'type': 'RESULT', 'citation': 'Lapi D, Scuri R, Colantuoni A. Trigeminal Cardiac Reflex and Cerebral Blood Flow Regulation. Front Neurosci. 2016 Oct 20;10:470. doi: 10.3389/fnins.2016.00470. eCollection 2016.'}, {'pmid': '36524908', 'type': 'RESULT', 'citation': 'Ulusoy S, Bayar Muluk N, Scadding GK, Passali GS, Dilber M, Gevaert P, Passali D, Resuli AS, Van Gerven L, Kalogjera L, Prokopakis E, Rombaux P, Hellings P, Cingi C. The intranasal trigeminal system: roles in rhinitis (allergic and non-allergic). Eur Rev Med Pharmacol Sci. 2022 Dec;26(2 Suppl):25-37. doi: 10.26355/eurrev_202212_30479.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to address these gaps by comparing the incidence of TCR during septoplasty performed using cold dissection versus electrocautery, while also incorporating a novel assessment of surgical force.', 'detailedDescription': "Septoplasty is one of the most commonly performed otorhinolaryngological procedures and is generally considered safe . However, it may be associated with rare but potentially serious autonomic reflexes, most notably the trigeminal cardiac reflex (TCR) . The TCR is a brainstem reflex characterized by sudden parasympathetic activation resulting in bradycardia, hypotension, arrhythmias, or even asystole following stimulation of the trigeminal nerve or its branches. Clinically, TCR is usually defined as a sudden reduction in heart rate exceeding 20% from baseline during trigeminal nerve stimulation . The trigeminal nerve provides rich sensory innervation to the nasal septum, particularly in the posterior septal region and near the sphenopalatine area. Surgical manipulation in these areas during septoplasty can trigger TCR, especially when the stimulus is intense or prolonged . While TCR has been extensively reported in neurosurgical, maxillofacial, and skull base procedures, its occurrence during nasal surgery is increasingly recognized but remains underreported and underinvestigated .\n\nSeveral factors are believed to influence the incidence and severity of TCR, including the type, intensity, and duration of trigeminal stimulation. Both mechanical stimulation, such as traction, pressure, or fracture of bone and cartilage, and thermal stimulation, such as electrocautery, can activate trigeminal afferents . Experimental and clinical observations suggest that thermal stimulation may produce a stronger and more sustained trigeminal response compared to mechanical manipulation alone, potentially leading to a higher incidence of TCR . Despite the widespread use of electrocautery for dissection and hemostasis during septoplasty, there is limited evidence directly comparing its impact on TCR incidence with that of cold steel dissection techniques. Cold dissection relies primarily on mechanical separation using scissors, chisels, and elevators, avoiding thermal injury to surrounding tissues and neural endings. Whether this difference in stimulus modality translates into a clinically significant difference in TCR incidence has not been systematically evaluatedData analysis will be carried out using SPSS (IBM SPSS Statistics) and/or R.\n\nContinuous variables will be expressed as mean ± standard deviation (SD) when normally distributed, or as median with interquartile range for non- normally distributed data. Categorical variables will be summarized as frequencies and percentages. A p-value of less than 0.05 (two-tailed) will be considered statistically significant. Group comparisons will be conducted using: Independent samples t-test for normally distributed continuous data, Mann-Whitney U test for skewed continuous data, Chi-square test or Fisher's exact test for categorical data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Randomization and Group Allocation Patients will be randomly allocated into two groups using computer-generated randomization:', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-60 years.\n* Indicated for primary septoplasty.\n* American Society of Anesthesiologists (ASA) physical status I-II.\n\nExclusion Criteria:\n\n* History of cardiac arrhythmias or conduction abnormalities.\n* Use of beta-blockers, calcium channel blockers, or antiarrhythmic drugs Previous nasal surgery.\n* Combined nasal procedures.\n* Intraoperative complications requiring deviation from the assigned technique.'}, 'identificationModule': {'nctId': 'NCT07425834', 'acronym': 'TCR', 'briefTitle': 'Cold Dissection vs Electrocautry on TCR in Septoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University Hospital'}, 'officialTitle': 'Impact of "Cold Dissection" vs. "Electrocautery" on the Incidence of TCR During Septoplasty', 'orgStudyIdInfo': {'id': 'R803'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group C (Cold Dissection Group)', 'description': 'Septoplasty performed using cold steel instruments only (scissors, elevators, chisels) for flap elevation and spur removal, with avoidance of electrocautery near the septal base.'}, {'label': 'Group E (Electrocautery Group)', 'description': 'Septoplasty performed using monopolar or bipolar electrocautery for dissection near the septal base and posterior septum.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63514', 'city': 'Al Fayyum', 'country': 'Egypt', 'facility': 'Fayoum University Hospital', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}], 'centralContacts': [{'name': 'Fatmaelzahraa O Bahr, Lecture', 'role': 'CONTACT', 'email': 'drfatmabahr85@gmail.com', 'phone': '00201097356769'}, {'name': 'Mohamed A Hamed, Professor', 'role': 'CONTACT', 'email': 'mah07@fayoum.edu.eg', 'phone': '00201010509736', 'phoneExt': '+201118560065'}], 'overallOfficials': [{'name': 'Mohamed A Hamed, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fayoum University Hospital'}, {'name': 'Fatmaelzahraa O Bahr, Lecture', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fayoum University Hospital'}, {'name': 'Mohamed E Khalil, Lecture', 'role': 'STUDY_CHAIR', 'affiliation': 'Fayoum University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatmaelzahraa Omar Mahmoud Bahr', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecture', 'investigatorFullName': 'Fatmaelzahraa Omar Mahmoud Bahr', 'investigatorAffiliation': 'Fayoum University Hospital'}}}}