- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02148432
Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: dexmedetomidine 0.5 mcg/kg/hr
|
continuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr
|
Active Comparator: dexmedetomidine 1.0 mcg/kg/hr
|
continuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Desaturation rate
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
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Disease
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Syndrome
- Apnea
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- 4-2014-0232
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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