Dexmedetomidine for Sedation Undergoing Bronchoscopy | NCT04169685

Studies
Dexmedetomidine for Sedation Undergoing Bronchoscopy

NCT04169685

Sponsor

Kaohsiung Medical University

Status

Unknown status

Last Update Posted

Nov 20, 2019Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Safety Issues

Interventions

bronchoscopy

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Jul 31, 2020Estimated

Completion Date

Jul 31, 2020Estimated

First Submitted Date

Nov 18, 2019

First Submission Date that Met QC Criteria

Nov 18, 2019

First Posted Date

Nov 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2019

Last Update Posted Date

Nov 20, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
with dexmedetomidine		Drugs provided moderate sedation during procedure including dexmedetomidine	Procedure: bronchoscopy
without dexmedetomidine		Drugs provided moderate sedation during procedure without dexmedetomidine	Procedure: bronchoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bronchoscopy	Procedure	during flexible bronchoscopy	with dexmedetomidine without dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
safety profile during procedure	Incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension	during procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sedation undergoing flexible bronchoscopy

Exclusion Criteria:

without sedation undergoing flexible bronchoscopy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients undergoing flexible bronchoscopy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
sheng hua sheng hua, MD, PHD	Contact	886-7-3121101	7035	elsawu2@gmail.com

Overall Officials

Name	Affiliation	Role
sheng hua wu, MD, PHD	Kaohsiung Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Medical University Hospital	Recruiting	Kaohsiung City			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001999	Bronchoscopy

Ancestor Terms

ID	Term
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

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Browse Branches

Not provided