Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2014
Typical duration for not_applicable
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
May 19, 2014
CompletedFirst Submitted
Initial submission to the registry
May 22, 2014
CompletedFirst Posted
Study publicly available on registry
May 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2016
CompletedJanuary 25, 2017
January 1, 2017
1.9 years
May 22, 2014
January 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Desaturation rate
SpO2 \< 90% (checked by pulse oximetry)
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
Study Arms (2)
dexmedetomidine 0.5 mcg/kg/hr
EXPERIMENTALdexmedetomidine 1.0 mcg/kg/hr
ACTIVE COMPARATORInterventions
continuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr
continuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr
Eligibility Criteria
You may qualify if:
- years old patients with ASA class I-II
- Scheduled for drug induced sleep endoscope after diagnosed with sleep apnea syndrome
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2014
First Posted
May 28, 2014
Study Start
May 19, 2014
Primary Completion
April 29, 2016
Study Completion
April 29, 2016
Last Updated
January 25, 2017
Record last verified: 2017-01