Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Nasal Sephoplasty Surgery.
Phase 4 Study of Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Surgical Conditions and Postoperative Analgesic Consumption in Nasal Sephoplasty Surgery.
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
It is very important to decrease the bleeding during nasal septoplasty in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and postoperative analgesic consumption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 surgery
Started Mar 2013
Shorter than P25 for phase_4 surgery
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
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 15, 2013
CompletedFirst Posted
Study publicly available on registry
October 17, 2013
CompletedOctober 17, 2013
October 1, 2013
6 months
October 15, 2013
October 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
surgical conditions
Bleeding scores were recorded during the surgery
during the surgery
Secondary Outcomes (1)
Analgesic Consumption
Up to 24 hours
Study Arms (2)
Lidocaine plus Adrenaline
ACTIVE COMPARATORLidocaine and adrenaline diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes from the surgery.
Dexmedetomidine
ACTIVE COMPARATOR2 mcg/kg dexmedetomidine diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes the surgery.
Interventions
2 mcg/kg dexmedetomidine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
10 ml 2% lidocaine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
12.5 mcg/ml 10 ml adrenaline was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
Eligibility Criteria
You may qualify if:
- Scheduled for the nasal septoplasty surgery
- ASA 1-2 patients
- yo patients
You may not qualify if:
- Pregnant patients
- ASA 3-4 patients
- Under 18 yo childrens
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adnan Bayram, MD
TC Erciyes University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst Prof
Study Record Dates
First Submitted
October 15, 2013
First Posted
October 17, 2013
Study Start
March 1, 2013
Primary Completion
September 1, 2013
Study Completion
October 1, 2013
Last Updated
October 17, 2013
Record last verified: 2013-10