NCT04169685

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

3.3 years

First QC Date

November 18, 2019

Last Update Submit

November 18, 2019

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

  • safety profile during procedure

    Incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension

    during procedure

Study Arms (2)

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

bronchoscopyPROCEDURE

during flexible bronchoscopy

with dexmedetomidinewithout dexmedetomidine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing flexible bronchoscopy

You may qualify if:

  • sedation undergoing flexible bronchoscopy

You may not qualify if:

  • without sedation undergoing flexible bronchoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • sheng hua wu, MD, PHD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

sheng hua sheng hua, MD, PHD

CONTACT

886-7-3121101elsawu2@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 20, 2019

Study Start

April 1, 2017

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

November 20, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)