Sedation by Dexmedetomidine and Propofol

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.

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Key information

Conditions

Anesthesia, Spinal

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Propofol

Drug

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

Primary outcomes

The occurrence of upper airway obstruction

Time frame: During 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Dec 15, 2016
Registry last updated: Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed