What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Patient Satisfaction for Bronchoscopy
Study Interventions
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:LorazepamLorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB
Drug:ControlPlacebo 1T po at night one day before FB and placebo 1T po 30min before the FB
Study Arms
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ControlPlacebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB
LorazepamLorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB
Study Status
Unknown status
Start Date: March 2010
Completed Date: December 2010
Phase: Phase 4
Type: Interventional
Design:
Primary Outcome: patient satisfaction
Secondary Outcome: relationship between patient satisfaction and sleep quality, anxiety level
Study sponsors, principal investigator, and references
Principal Investigator: Seok-Chul Yang, MD
Lead Sponsor: Seoul National University Hospital
Collaborator:
More information:https://clinicaltrials.gov/show/NCT01121055
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