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

NCT01895348 | Completed Phase 4

• 1 other identifier: 4-2012-0291
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

propofol only

ACTIVE COMPARATOR

Drug: Propofol

propofol-remifentanil

ACTIVE COMPARATOR

Drug: propofol-remifentanil

dexmedetomidine-remifentanil

ACTIVE COMPARATOR

Drug: Dexmedetomidine-remifentanil

Interventions

Propofol DRUG

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 only

propofol-remifentanil DRUG

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

propofol-remifentanil

Dexmedetomidine-remifentanil DRUG

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

dexmedetomidine-remifentanil

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA class 1, 2
• Age ≥ 20 yrs
• undergoing drug-induced endoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Propofol

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: July 10, 2013
• Study Start: July 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

KR (1)