A Comparison of Surgical Outcome Following Drug-induced Sleep Endoscopic Diagnosis Using Propofol or Dexmedetomidine for Sedation : A Prospective Randomized Trial
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propofol
propofol-remifentanil
Dexmedetomidine-remifentanil
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- ASA class 1, 2
- Age ≥ 20 yrs
- undergoing drug-induced endoscopy
Exclusion Criteria:
- patient's reject
- patients with hearing impairment or neurological deficits
- patients taking medicine that can affect the central nervous system
- History of adverse drug reactions
- Glasgow coma scale ≤ 15
- could not undergo the endoscopy
- could undergo the endoscopy, but do not undergo UPPP
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
propofol only
propofol-remifentanil
dexmedetomidine-remifentanil
Arm Description
Outcomes
Primary Outcome Measures
Desaturation rate
SpO2 < 90% (checked by pulse oximetry)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01895348
Brief Title
A Comparison of Surgical Outcome Following Drug-induced Sleep Endoscopic Diagnosis Using Propofol or Dexmedetomidine for Sedation : A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
5. Study Description
Brief Summary
Obstructive sleep apnea is a common disease, associated with cardiovascular disease, cerebrovascular disease, and many other medical conditions. Therefore the precise diagnosis and treatment are important. With drug-induced sleep endoscopy (DISE), the three-dimensional evaluation of upper airway and airway obstruction could be possible. The problem of the DISE is that there is the difference between a sedative-induced sleep and normal sleep. Moreover there were no standard sedation protocol of DISE. Propofol has short half-life, about 3 minutes, so the patients could recover quickly from it. In recent years, using target controlled infusion(TCI) of propofol, the effective effect-site concentration for DISE could be reached easily with hemodynamic stability and minimal toxic effect. In a previous pilot study, the endoscopy for the diagnosis of sleep apnea could be done successfully with propofol TCI. However there were some desaturation events, although the EEG showed that the patient was not in deep sleep enough. Therefore we thought that not only further study of propofol for DISE but also the study of other drugs for DISE will be needed to overcome this limitation. Dexmedetomidine, the selective α2-adrenoreceptor agonist, has analgesic effect and almost no respiratory depression, therefore it could be a good alternative drug for DISE. The purpose of this study is designing the appropriate sedation protocol for DISE using propofol or dexmedetomidine, and enabling the safer and more accurate DISE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
propofol only
Arm Type
Active Comparator
Arm Title
propofol-remifentanil
Arm Type
Active Comparator
Arm Title
dexmedetomidine-remifentanil
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol TCI: effect-site concentration(Ce): Ce was titrated to 1.0 μg/ml and increased by 0.2 μg/ml every five minutes
Intervention Type
Drug
Intervention Name(s)
propofol-remifentanil
Intervention Description
Propofol TCI: effect-site concentration(Ce): Ce was titrated to 1.0 μg/ml and increased by 0.2 μg/ml every five minutes Remifentanil TCI: effect-site concentration(Ce): Ce was titrated to 1.5 μg/ml
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine-remifentanil
Intervention Description
Dexmedetomidine infusion: After the loading dose (1 mcg/kg for 10 minutes), the continuous infusion was done (0.2 mcg/kg/hr) and the infusion rate was increased by 0.2 mcg/kg/hr every five minutes (maximum infusion rate: 1.4 mcg/kg/hr) Remifentanil TCI: effect-site concentration(Ce): Ce was titrated to 1.5 μg/ml
Primary Outcome Measure Information:
Title
Desaturation rate
Description
SpO2 < 90% (checked by pulse oximetry)
Time Frame
Baseline / 5 min after remifentanil TCI start / 5 min after propofol TCI start or 10 min after dexmedetomidine loading start / every 5 min until surgeon can do endoscopy successfully / immediately after endoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA class 1, 2
Age ≥ 20 yrs
undergoing drug-induced endoscopy
Exclusion Criteria:
patient's reject
patients with hearing impairment or neurological deficits
patients taking medicine that can affect the central nervous system
History of adverse drug reactions
Glasgow coma scale ≤ 15
could not undergo the endoscopy
could undergo the endoscopy, but do not undergo UPPP
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Surgical Outcome Following Drug-induced Sleep Endoscopic Diagnosis Using Propofol or Dexmedetomidine for Sedation : A Prospective Randomized Trial
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