Sedation by Dexmedetomidine and Propofol

NCT ID: NCT02993718

Last Updated: 2017-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Anesthesia, Spinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dexmedetomidine

Intraoperative sedation is performed by using dexmedetomidine.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type 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

Intraoperative sedation is performed by using propofol

Group Type EXPERIMENTAL

Propofol

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 30185146 (View on PubMed)

Other Identifiers

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WatchPAT

Identifier Type: -

Identifier Source: org_study_id

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