Dexmedetomidine for Sedation Undergoing Bronchoscopy

November 18, 2019 updated by: Sheng-Hua Wu, Kaohsiung Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: sheng hua sheng hua, MD, PHD
  • Phone Number: 7035 886-7-3121101
  • Email: elsawu2@gmail.com

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Recruiting
        • Kaohsiung Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients undergoing flexible bronchoscopy

Description

Inclusion Criteria:

  • sedation undergoing flexible bronchoscopy

Exclusion Criteria:

  • without sedation undergoing flexible bronchoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
with dexmedetomidine
Drugs provided moderate sedation during procedure including dexmedetomidine
Procedure: bronchoscopy
during flexible bronchoscopy
without dexmedetomidine
Drugs provided moderate sedation during procedure without dexmedetomidine
Procedure: bronchoscopy
during flexible bronchoscopy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University

Investigators

  • Principal Investigator: sheng hua wu, MD, PHD, Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2017

Primary Completion (ANTICIPATED)

July 31, 2020

Study Completion (ANTICIPATED)

July 31, 2020

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (ACTUAL)

November 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • KMUHIRB-E(I)-20190221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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