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NCT04169685 Clinical Trial

Dexmedetomidine for Sedation Undergoing Bronchoscopy

Safety Issues Clinical Trial

Official title:
Comparison of Dexmedetomidine and Propofol for Sedation in Adult Patients Undergoing Flexible Bronchoscopy -A Retrospective Review

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04169685
Other study ID # KMUHIRB-E(I)-20190221
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date July 31, 2020

Study information
Verified date November 2019
Source Kaohsiung Medical University
Contact sheng hua sheng hua, MD, PHD
Phone 886-7-3121101
Email elsawu2@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Several sedatives or analgesics can be used to achieve appropriate levels of sedation for endoscopic procedures. Dexmedetomide is notable for providing sedation without respiratory depression. We hypothesized dexmedetomide is more suitable for sedation of bronchoscopy than other sedative drugs.

Description:

A retrospective chart review was conducted. All patients undergoing flexible bronchoscopy with moderate sedation were enrolled.The primary analysis outcome was safety profile during procedure included incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension. The secondary outcome was measured by recovery profile (awake and ambulation time).

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date July 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- sedation undergoing flexible bronchoscopy

Exclusion Criteria:

- without sedation undergoing flexible bronchoscopy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• bronchoscopy
during flexible bronchoscopy

Locations
Country Name City State
Taiwan Kaohsiung Medical University Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary safety profile during procedure Incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension during procedure
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