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

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: propofol-remifentanil; Drug: Dexmedetomidine-remifentanil; Drug: Propofol

• Registration Number: NCT01895348
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-07-04
• Study First Posted: 2013-07-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol-remifentanil	propofol-remifentanil	-
dexmedetomidine-remifentanil	Dexmedetomidine-remifentanil	-
propofol only	Propofol	-

Primary Outcome Measures

Name	Time	Method
Desaturation rate	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)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of