NCT01569048

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DRUG	Propofol 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
DRUG	propofol 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

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-04-02
• Last updated: 2014-03-05

Locations

1 site across 1 country: South Korea