Sedation by Dexmedetomidine and Propofol
Comparison of the Upper Airway Patency by Dexmedetomidine and Propofol Used for Sedation
1 other identifier
interventional
52
1 country
1
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.
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 Jan 2015
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
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 11, 2016
CompletedFirst Posted
Study publicly available on registry
December 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedSeptember 14, 2017
September 1, 2017
2.4 years
December 11, 2016
September 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The occurrence of upper airway obstruction
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.
During the sedation period, an average of 3 hours.
Study Arms (2)
Dexmedetomidine
EXPERIMENTALIntraoperative sedation is performed by using dexmedetomidine.
Propofol
EXPERIMENTALIntraoperative sedation is performed by using propofol
Interventions
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 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Anatomical defects on upper respiratory tract
- Psychotic disorder
- Drug addition
- Alcohol addition
- body mass index ≥ 35 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Related Publications (1)
Shin HJ, Kim EY, Hwang JW, Do SH, Na HS. Comparison of upper airway patency in patients with mild obstructive sleep apnea during dexmedetomidine or propofol sedation: a prospective, randomized, controlled trial. BMC Anesthesiol. 2018 Sep 5;18(1):120. doi: 10.1186/s12871-018-0586-5.
PMID: 30185146DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 11, 2016
First Posted
December 15, 2016
Study Start
January 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
September 14, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share