Randomized Controlled Trial to Evaluate of Dexmedetomidine for the Effect on Operative Visibility in Patients Undergoing Endoscopic Sinus Surgery
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 23, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMarch 5, 2014
March 1, 2014
1.9 years
March 23, 2012
March 4, 2014
Conditions
Outcome Measures
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
Within 1 day of endoscopic sinus surgery finish including dressing of surgical wound
Study Arms (2)
remifentanil
ACTIVE COMPARATORdexmedetomidine
EXPERIMENTALInterventions
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
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
Eligibility Criteria
You may qualify if:
- ASA Ⅰ-Ⅱ
- Aged between 20 and 70 year
- General anesthesia for endoscopic sinus surgery
You may not qualify if:
- Body mass index \>30
- Congestive heart failure, Sinus Bradycardia(\<50 BPM), Uncontrolled hypertension,
- Coagulopathy
- Drug addiction
- Pregnancy
- Allergic fungal infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2012
First Posted
April 2, 2012
Study Start
March 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 5, 2014
Record last verified: 2014-03