Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy
1 other identifier
interventional
372
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 9, 2010
CompletedFirst Posted
Study publicly available on registry
May 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMay 31, 2010
May 1, 2010
5 months
May 9, 2010
May 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patient satisfaction
within 24 hr of bronchoscopy
Secondary Outcomes (1)
relationship between patient satisfaction and sleep quality, anxiety level
24hr before and after bronchoscopy
Study Arms (2)
Control
PLACEBO COMPARATORPlacebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB
Lorazepam
EXPERIMENTALLorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients (aged 18 years or older) admitted to the Respiratory Department
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 9, 2010
First Posted
May 12, 2010
Study Start
March 1, 2010
Primary Completion
August 1, 2010
Study Completion
December 1, 2010
Last Updated
May 31, 2010
Record last verified: 2010-05