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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02148432
Enrollment
31
Registered
2014-05-28
Start date
2014-05-19
Completion date
2016-04-29
Last updated
2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndrome

Keywords

sleep apnea syndrome, fiberoptic bronchoscopy, IV sedation

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.

Interventions

DRUGdexmedetomidine infusion rate, 0.5 mcg/kg/hr

continuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr

DRUGdexmedetomidine infusion rate, 1.0 mcg/kg/hr

continuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Desaturation rateBaseline 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 endoscopySpO2 \< 90% (checked by pulse oximetry)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026