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Sedation by Dexmedetomidine and Propofol

Comparison of the Upper Airway Patency by Dexmedetomidine and Propofol Used for Sedation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02993718
Enrollment
52
Registered
2016-12-15
Start date
2015-01-31
Completion date
2017-06-30
Last updated
2017-09-14

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

Conditions

Anesthesia, Spinal

Brief summary

Under the hypothesis that dexmedetomidine sedation would result in less upper airway obstruction, we evaluated the occurrence of upper airway collapse or the requirement of airway intervention in patients with obstructive sleep apnea during dexmedetomidine or propofol sedation.

Interventions

DRUGDexmedetomidine

As a loading dose, 0.5 μg/kg dexmedetomidine was administered over 10 min, which was then administered continuously at a dose of 0.2-0.8 μg/kg/h. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3

DRUGPropofol

Propofol was infused continuously via a target-controlled infusion device, and the effect-site concentration was maintained with a range of 0.5-2.0 μg/ml. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Surgery under spinal anesthesia * Intraoperative sedation * American Society of Anesthesiology physical status 1 or 2 * Apnea/hypopnea index 5-14/h in Watch-PAT 200 analysis

Exclusion criteria

* Anatomical defects on upper respiratory tract * Psychotic disorder * Drug addition * Alcohol addition * body mass index ≥ 35 kg/m2

Design outcomes

Primary

MeasureTime frameDescription
The occurrence of upper airway obstructionDuring the sedation period, an average of 3 hours.When end-tidal carbon dioxide was not detected in spite of the respiratory effort during the sedation period, the case will be regarded as the occurrence of upper airway obstruction.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026