Cold Dissection vs Electrocautry on TCR in Septoplasty
TCR
Impact of "Cold Dissection" vs. "Electrocautery" on the Incidence of TCR During Septoplasty
1 other identifier
observational
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
February 24, 2026
February 1, 2026
9 months
February 14, 2026
February 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of TCR
Defined as a decrease in heart rate \>20% from baseline during surgery
3 hours from induction
Secondary Outcomes (2)
Magnitude of heart rate reduction
3 hours from induction
Intraoperative hypotension or arrhythmias
3 hours from induction
Study Arms (2)
Group C (Cold Dissection Group)
Septoplasty performed using cold steel instruments only (scissors, elevators, chisels) for flap elevation and spur removal, with avoidance of electrocautery near the septal base.
Group E (Electrocautery Group)
Septoplasty performed using monopolar or bipolar electrocautery for dissection near the septal base and posterior septum.
Eligibility Criteria
Randomization and Group Allocation Patients will be randomly allocated into two groups using computer-generated randomization:
You may qualify if:
- Age 18-60 years.
- Indicated for primary septoplasty.
- American Society of Anesthesiologists (ASA) physical status I-II.
You may not qualify if:
- History of cardiac arrhythmias or conduction abnormalities.
- Use of beta-blockers, calcium channel blockers, or antiarrhythmic drugs Previous nasal surgery.
- Combined nasal procedures.
- Intraoperative complications requiring deviation from the assigned technique.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fayoum University Hospital
Al Fayyum, 63514, Egypt
Related Publications (2)
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: 27812317RESULTUlusoy 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.
PMID: 36524908RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed A Hamed, Professor
Fayoum University Hospital
- STUDY DIRECTOR
Fatmaelzahraa O Bahr, Lecture
Fayoum University Hospital
- STUDY CHAIR
Mohamed E Khalil, Lecture
Fayoum University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecture
Study Record Dates
First Submitted
February 14, 2026
First Posted
February 23, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share