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

Primary Purpose

Chronic Sinusitis

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Propofol and dexmedetomidine

propofol and remifentanil

About this trial

This is an interventional prevention trial for Chronic Sinusitis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

remifentanil

dexmedetomidine

Arm Description

Outcomes

Primary Outcome Measures

surgical satisfaction about visibility of operative field

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01569048

First Posted

March 23, 2012

Last Updated

March 4, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01569048

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Sinusitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

remifentanil

Arm Type

Active Comparator

Arm Title

dexmedetomidine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Propofol and dexmedetomidine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

propofol and remifentanil

Intervention Description

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 Outcome Measure Information:

Title

surgical satisfaction about visibility of operative field

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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