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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01569048
First received: March 23, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Chronic Sinusitis
Drug: Propofol and dexmedetomidine
Drug: propofol and remifentanil
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • surgical satisfaction about visibility of operative field [ Time Frame: Within 1 day of endoscopic sinus surgery finish including dressing of surgical wound ] [ Designated as safety issue: No ]
    subjective satisfaction about visibility of operative field by surgeon/ numerous rating scale / 0: worst - 10:best


Enrollment: 66
Study Start Date: March 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: remifentanil 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
Experimental: dexmedetomidine 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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01569048

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01569048     History of Changes
Other Study ID Numbers: 4-2012-0023
Study First Received: March 23, 2012
Last Updated: March 4, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Propofol
Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 26, 2014