Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy

May 27, 2010 updated by: Seoul National University Hospital
Many patients undergoing flexible bronchoscopy (FB) experience anxiety and discomfort during the procedure. The investigators want to evaluate whether an additional Lorazepam premedication would improve patient satisfaction for FB.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The enrolled patients are randomized to either the control or Lorazepam groups according to a random sample chart of numbers. The patients complete questionnaires about baseline anxiety level and satisfaction for FB within 24 hours after the FB.

Study Type

Interventional

Enrollment (Anticipated)

372

Phase

  • Phase 4

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

Study Contact Backup

  • Name: Seok-Chul Yang, MD, PhD
  • Phone Number: +82-2-2072-0354
  • Email: scyang@snu.ac.kr

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (aged 18 years or older) admitted to the Respiratory Department

Exclusion Criteria:

  • outpatient procedures
  • therapeutic bronchoscopy
  • expected operation or discharge within 24 hours after the FB
  • sedative premedication
  • endotracheal intubation with mechanical ventilation
  • inability to speak Korean

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Placebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB
Drug: Control
Placebo 1T po at night one day before FB and placebo 1T po 30min before the FB
Experimental: Lorazepam
Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB
Drug: Lorazepam
Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patient satisfaction
Time Frame: within 24 hr of bronchoscopy
within 24 hr of bronchoscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
relationship between patient satisfaction and sleep quality, anxiety level
Time Frame: 24hr before and after bronchoscopy
24hr before and after bronchoscopy

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Seok-Chul Yang, MD, Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine

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

March 1, 2010

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

May 9, 2010

First Submitted That Met QC Criteria

May 9, 2010

First Posted (Estimate)

May 12, 2010

Study Record Updates

Last Update Posted (Estimate)

May 31, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lorazepam in FB

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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