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

NCT ID: NCT01121055

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patient Satisfaction for Bronchoscopy

Keywords

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Fiberoptic Bronchoscopy Patient Satisfaction Lorazepam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Placebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

Placebo 1T po at night one day before FB and placebo 1T po 30min before the FB

Lorazepam

Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB

Group Type EXPERIMENTAL

Lorazepam

Intervention Type DRUG

Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB

Interventions

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Lorazepam

Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB

Intervention Type DRUG

Control

Placebo 1T po at night one day before FB and placebo 1T po 30min before the FB

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine

Principal Investigators

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Seok-Chul Yang, MD

Role: STUDY_CHAIR

Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seok-Chul Yang, MD, PhD

Role: CONTACT

Phone: +82-2-2072-0354

Email: [email protected]

Jong Sun Park, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Seok-Chul Yang, MD

Role: primary

Jong Sun Park, MD

Role: backup

Other Identifiers

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Lorazepam in FB

Identifier Type: -

Identifier Source: org_study_id