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Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome

Primary Purpose

Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
dexmedetomidine infusion rate, 0.5 mcg/kg/hr
dexmedetomidine infusion rate, 1.0 mcg/kg/hr
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep Apnea Syndrome focused on measuring sleep apnea syndrome, fiberoptic bronchoscopy, IV sedation

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 20-60 years old patients with ASA class I-II
  2. Scheduled for drug induced sleep endoscope after diagnosed with sleep apnea syndrome

Exclusion Criteria:

  1. Patients having hearing difficulties, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale < 15
  2. Patients with severe cardiopulmonary dysfunction
  3. Patients refusal

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dexmedetomidine 0.5 mcg/kg/hr

dexmedetomidine 1.0 mcg/kg/hr

Arm Description

Outcomes

Primary Outcome Measures

Desaturation rate
SpO2 < 90% (checked by pulse oximetry)

Secondary Outcome Measures

Full Information

First Posted
May 22, 2014
Last Updated
January 23, 2017
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02148432
Brief Title
Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 19, 2014 (Actual)
Primary Completion Date
April 29, 2016 (Actual)
Study Completion Date
April 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. The American College of Chest Physicians (ACCP) had published evidence-based clinical practice guideline for VTE prophylaxis. This study focuses on how VTE prophylaxis is being performed in both medical and surgical ICUs in a single University hospital, and sees the differences in such prophylactic patterns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome
Keywords
sleep apnea syndrome, fiberoptic bronchoscopy, IV sedation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine 0.5 mcg/kg/hr
Arm Type
Experimental
Arm Title
dexmedetomidine 1.0 mcg/kg/hr
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine infusion rate, 0.5 mcg/kg/hr
Intervention Description
continuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine infusion rate, 1.0 mcg/kg/hr
Intervention Description
continuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr
Primary Outcome Measure Information:
Title
Desaturation rate
Description
SpO2 < 90% (checked by pulse oximetry)
Time Frame
Baseline from 5 min after remifentanil TCI start, 10 min after dexmedetomidine loading start, every 5 min until surgeon can do endoscopy successfully, to immediately after endoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 20-60 years old patients with ASA class I-II Scheduled for drug induced sleep endoscope after diagnosed with sleep apnea syndrome Exclusion Criteria: Patients having hearing difficulties, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale < 15 Patients with severe cardiopulmonary dysfunction Patients refusal
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome

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