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

Chronic Sinusitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569048
• Other study ID #: 4-2012-0023
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2012
• Last updated: March 4, 2014
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA ?-?

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Sinusitis

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical satisfaction about visibility of operative field	subjective satisfaction about visibility of operative field by surgeon/ numerous rating scale / 0: worst - 10:best	Within 1 day of endoscopic sinus surgery finish including dressing of surgical wound	No