Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Nasal Sephoplasty Surgery.

Phase 4

Completed

• Conditions: Surgery; Pain
• Interventions: Drug: Dexmedetomidine; Drug: Lidocaine; Drug: Adrenaline

• Registration Number: NCT01964586
• Lead Sponsor: TC Erciyes University

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.

Detailed Description

Nasal septoplasty is a surgery procedure which needs to have decrease the bleeding during the surgery for the visibility of surgical site.And postoperative pain is very usual after the surgery, so an effective postoperative analgesia procedure reduces the complications and helps to be discharged earlier from the hospital. An alpha 2 agonist Dexmedetomidine has an analgesic effect and vasoconstructive effect on the periferal blood vessels. Our hypothesis was dexmedetomidine makes a better surgecal conditions during the surgery and reduce the postoperative analgesic consumption. We administered the infiltrated dexmedetomidine or lidocaine plus adrenaline to the both side of the nasal septum 10 minutes before the surgery. Bleeding scores (Fromm and Boezaart Bleeding Scores) were recorded during the surgery. And postoperative analgesic consumptions were recorded in first 24 hours after the surgery.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-09
• Status Verified: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-15
• Last Update Submitted: 2013-10-15
• Study First Posted: 2013-10-17
• Last Update Posted: 2013-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Scheduled for the nasal septoplasty surgery
• ASA 1-2 patients
• 18-60 yo patients

Exclusion Criteria

• Pregnant patients
• ASA 3-4 patients
• Under 18 yo childrens

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	2 mcg/kg dexmedetomidine diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes the surgery.
Lidocaine plus Adrenaline	Lidocaine	Lidocaine and adrenaline diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes from the surgery.
Lidocaine plus Adrenaline	Adrenaline	Lidocaine and adrenaline diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes from the surgery.

Primary Outcome Measures

Name	Time	Method
surgical conditions	during the surgery	Bleeding scores were recorded during the surgery

Secondary Outcome Measures

Name	Time	Method
Analgesic Consumption	Up to 24 hours	Analgesic consumption were recorded.