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

October 15, 2013 updated by: Adnan Bayram, TC Erciyes University

Phase 4 Study of Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Surgical Conditions and Postoperative Analgesic Consumption in Nasal Sephoplasty Surgery.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine plus 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.
Drug: Lidocaine
10 ml 2% lidocaine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
Other Names:
  • Jetokain %2
Drug: Adrenaline
12.5 mcg/ml 10 ml adrenaline was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
Other Names:
  • Adrenalin
  • Epinefrin
Active Comparator: 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.
Drug: Dexmedetomidine
2 mcg/kg dexmedetomidine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical conditions
Time Frame: during the surgery
Bleeding scores were recorded during the surgery
during the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic Consumption
Time Frame: Up to 24 hours
Analgesic consumption were recorded.
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: Adnan Bayram, MD, TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 15, 2013

First Posted (Estimate)

October 17, 2013

Study Record Updates

Last Update Posted (Estimate)

October 17, 2013

Last Update Submitted That Met QC Criteria

October 15, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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