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

Obstructive Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895348
• Other study ID #: 4-2012-0291
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2013
• Last updated: August 16, 2016
• Start date: July 2012
• Est. completion date: May 2015

Study information

• Verified date: August 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desaturation rate	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	No