Sedation by Dexmedetomidine and Propofol

Not Applicable

Completed

• Conditions: Anesthesia, Spinal
• Interventions: Drug: Propofol; Drug: Dexmedetomidine

• Registration Number: NCT02993718
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-12-11
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-15
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Intraoperative sedation is performed by using propofol
Dexmedetomidine	Dexmedetomidine	Intraoperative sedation is performed by using dexmedetomidine.

Primary Outcome Measures

Name	Time	Method
The occurrence of upper airway obstruction	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.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of