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

NCT01895348 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-08-17

No results posted yet for this study

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

Interventions

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

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

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01895348 on ClinicalTrials.gov