MedDataX Logo

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

NCT ID: NCT01964586

Last Updated: 2013-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Septoplasty, Dexmedetomidine, Surgical Conditions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

10 ml 2% lidocaine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.

Adrenaline

Intervention Type DRUG

12.5 mcg/ml 10 ml adrenaline was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

2 mcg/kg dexmedetomidine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

2 mcg/kg dexmedetomidine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.

Intervention Type DRUG

Lidocaine

10 ml 2% lidocaine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Precedex Jetokain %2 Adrenalin Epinefrin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adnan Bayram

Asst Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Adnan Bayram, MD

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013/167

Identifier Type: -

Identifier Source: org_study_id