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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01964586

Enrollment

Registered

2013-10-17

Start date

2013-03-31

Completion date

2013-10-31

Last updated

2013-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Surgery

Keywords

Septoplasty, Dexmedetomidine, Surgical Conditions

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.

Interventions

DRUGDexmedetomidine

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

DRUGLidocaine

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

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
surgical conditions	during the surgery	Bleeding scores were recorded during the surgery

Secondary

Measure	Time frame	Description
Analgesic Consumption	Up to 24 hours	Analgesic consumption were recorded.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026