Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome

NCT ID: NCT02148432

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-19

Study Completion Date

2016-04-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Venous thromboembolism(VTE) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. VTE often occurs in intensive care patients and there had been many efforts to prevent such complication. The American College of Chest Physicians (ACCP) had published evidence-based clinical practice guideline for VTE prophylaxis.

This study focuses on how VTE prophylaxis is being performed in both medical and surgical ICUs in a single University hospital, and sees the differences in such prophylactic patterns.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dexmedetomidine 0.5 mcg/kg/hr

Group Type EXPERIMENTAL

dexmedetomidine infusion rate, 0.5 mcg/kg/hr

Intervention Type DRUG

continuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr

dexmedetomidine 1.0 mcg/kg/hr

Group Type ACTIVE_COMPARATOR

dexmedetomidine infusion rate, 1.0 mcg/kg/hr

Intervention Type DRUG

continuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dexmedetomidine infusion rate, 0.5 mcg/kg/hr

continuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr

Intervention Type DRUG

dexmedetomidine infusion rate, 1.0 mcg/kg/hr

continuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 20-60 years old patients with ASA class I-II
2. Scheduled for drug induced sleep endoscope after diagnosed with sleep apnea syndrome

Exclusion Criteria

1. Patients having hearing difficulties, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale \< 15
2. Patients with severe cardiopulmonary dysfunction
3. Patients refusal
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, Seoul, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4-2014-0232

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.