Skip to main content
OpenTrials
Completed

NCT Number: NCT01569048

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Sinusitis

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol and dexmedetomidine

Drug

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

Drug

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

Primary outcomes

  1. surgical satisfaction about visibility of operative field

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 2, 2012
Registry last updated
Mar 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.