Randomized Controlled Trial to Evaluate of Dexmedetomidine for the Effect on Operative Visibility in Patients Undergoing Endoscopic Sinus Surgery

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01569048

Enrollment

Registered

2012-04-02

Start date

2012-03-31

Completion date

2014-02-28

Last updated

2014-03-05

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

Conditions

Chronic Sinusitis

Brief summary

Various maneuvers are commonly used to achieve the ideal operative field necessary for successful endoscopic sinus surgery (ESS). Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response. And dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during intranasal operation. The aim of this study is to compare the effect of dexmedetomidine, an alpha2-adrenoreceptor agonist, on intraoperative bleeding, propofol requirement and postoperative profiles to remifentanil , an ultrashort-acting opioid.

Interventions

DRUGPropofol and dexmedetomidine

Both group : propofol effect site TCI 2-4 mcg/ml, Remifentanil group : remifentanil effect site-TCI 2-4ng/ml Dexmedetomidine group: dexmedetomidine 0.5mcg/kg loading and 0.5mcg/kg/hr infusion

DRUGpropofol and remifentanil

Both group : propofol effect site TCI 2-4 mcg/ml, Remifentanil group : remifentanil effect site-TCI 2-4ng/ml Dexmedetomidine group: dexmedetomidine 0.5mcg/kg loading and 0.5mcg/kg/hr infusion

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

* ASA Ⅰ-Ⅱ * Aged between 20 and 70 year * General anesthesia for endoscopic sinus surgery

Exclusion criteria

* Body mass index \>30 * Congestive heart failure, Sinus Bradycardia(\<50 BPM), Uncontrolled hypertension, * Coagulopathy * Drug addiction * Pregnancy * Allergic fungal infection

Design outcomes

Primary

Measure	Time frame	Description
surgical satisfaction about visibility of operative field	Within 1 day of endoscopic sinus surgery finish including dressing of surgical wound	subjective satisfaction about visibility of operative field by surgeon/ numerous rating scale / 0: worst - 10:best

Countries

South Korea

Outcome results

None listed

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