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CompletedNCT01569048Updated Mar 5, 2014

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

A Phase 4 interventional study of Propofol and dexmedetomidine and propofol and remifentanil in Chronic Sinusitis, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-03-05.

Sponsored by Yonsei University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
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Study 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.

02

Conditions studied

  • Chronic Sinusitis

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03

In context

Sinusitis

415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.

This study's enrollment of 66 is close to the median of 60 across 313 interventional studies indexed under Sinusitis.

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Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Body mass index >30
  • Congestive heart failure, Sinus Bradycardia(\<50 BPM), Uncontrolled hypertension,
  • Coagulopathy
  • Drug addiction
  • Pregnancy
  • Allergic fungal infection
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
66 participants (actual)

Study arms

  • Active comparator
    remifentanil

    Drug: propofol and remifentanil

  • Experimental
    dexmedetomidine

    Drug: Propofol and dexmedetomidine

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

06

What researchers measure

Primary outcomes

  1. surgical satisfaction about visibility of operative field

    subjective satisfaction about visibility of operative field by surgeon/ numerous rating scale / 0: worst - 10:best

    Time frame: Within 1 day of endoscopic sinus surgery finish including dressing of surgical wound

07

Study locations

1 site
  • Severance Hospital
    Seoul, 120-752, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01569048
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Apr 2, 2012
Start date
Mar 2012
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Mar 5, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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