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

Sleep Apnea Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148432
• Other study ID #: 4-2014-0232
• Status: Completed
• Phase: N/A
• First received: May 22, 2014
• Last updated: January 23, 2017
• Start date: May 19, 2014
• Est. completion date: April 29, 2016

Study information

• Verified date: January 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 29, 2016
• Est. primary completion date: April 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Syndrome

Intervention

Drug:
• dexmedetomidine infusion rate, 0.5 mcg/kg/hr
continuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr
• dexmedetomidine infusion rate, 1.0 mcg/kg/hr
continuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Severance Hospital, 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 from 5 min after remifentanil TCI start, 10 min after dexmedetomidine loading start, every 5 min until surgeon can do endoscopy successfully, to immediately after endoscopy