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CompletedNCT01964586Updated Oct 17, 2013

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

A Phase 4 interventional study of Dexmedetomidine and Lidocaine in Surgery and Pain, sponsored by TC Erciyes University. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-10-17.

Sponsored by TC Erciyes University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Surgery
  • Pain

Keywords

  • Septoplasty, Dexmedetomidine, Surgical Conditions
03

In context

Lead sponsor

TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant patients
  • ASA 3-4 patients
  • Under 18 yo childrens
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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 · Drug: Adrenaline

  • 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

Interventions

  • DrugDexmedetomidine

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

    Also known as: Precedex

  • DrugLidocaine

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

    Also known as: Jetokain %2

  • DrugAdrenaline

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

    Also known as: Adrenalin, Epinefrin

06

What researchers measure

Primary outcomes

  1. surgical conditions

    Bleeding scores were recorded during the surgery

    Time frame: during the surgery

Secondary outcomes

  1. Analgesic Consumption

    Analgesic consumption were recorded.

    Time frame: Up to 24 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01964586
Lead sponsor
TC Erciyes University
Responsible party
Adnan Bayram (Asst Prof, TC Erciyes University) — Principal investigator
First posted
Oct 17, 2013
Start date
Mar 2013
Primary completion
Sep 2013
Completion
Oct 2013
Last update
Oct 17, 2013

Study contacts

Adnan Bayram, MD
principal investigator · TC Erciyes University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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