Sedation by Dexmedetomidine and Propofol

Anesthesia, Spinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993718
• Other study ID #: WatchPAT
• Status: Completed
• Phase: N/A
• First received: December 11, 2016
• Last updated: September 12, 2017
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Spinal

Intervention

Drug:
• Dexmedetomidine
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
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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.