A Comparison of Surgical Outcome Following Drug-induced Sleep Endoscopic Diagnosis Using Propofol or Dexmedetomidine for Sedation : A Prospective Randomized Trial

August 16, 2016 updated by: Yonsei University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: propofol only
Drug: Propofol
Propofol TCI: effect-site concentration(Ce): Ce was titrated to 1.0 μg/ml and increased by 0.2 μg/ml every five minutes
Active Comparator: propofol-remifentanil
Drug: propofol-remifentanil
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
Active Comparator: dexmedetomidine-remifentanil
Drug: Dexmedetomidine-remifentanil
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Desaturation rate
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
SpO2 < 90% (checked by pulse oximetry)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2012-0291

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