Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Patient Satisfaction for Bronchoscopy |
| Intervention | Drug: Lorazepam Drug: Control |
| Phase | Phase 4 |
| Sponsor | Seoul National University Hospital |
| Responsible Party | Seoul National University Hospital |
| ClinicalTrials.gov Identifier | NCT01121055 |
| First Received | May 9, 2010 |
| Last Updated | May 27, 2010 |
| Last verified | May 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 9, 2010 |
|---|---|
| Last Updated Date | May 27, 2010 |
| Start Date | March 2010 |
| Estimated Primary Completion Date | December 2010 |
| Current Primary Outcome Measures | patient satisfaction [Time Frame: within 24 hr of bronchoscopy] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | relationship between patient satisfaction and sleep quality, anxiety level [Time Frame: 24hr before and after bronchoscopy] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy |
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| Official Title | Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy |
| 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. |
| 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 |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care |
| Condition | Patient Satisfaction for Bronchoscopy |
| Intervention | Drug: Lorazepam Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB Drug: Control Placebo 1T po at night one day before FB and placebo 1T po 30min before the FB |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 372 |
| Estimated Completion Date | December 2010 |
| Estimated Primary Completion Date | August 2010 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Seok-Chul Yang, MD, PhD +82-2-2072-0354 scyang@snu.ac.kr |
| Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01121055 |
|---|---|
| Other Study ID Numbers | Lorazepam in FB |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Seoul National University Hospital |
| Study Sponsor | Seoul National University Hospital |
| Collaborators | Not Provided |
| 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 |
| Verification Date | May 2010 |
Locations[ + expand ][ + ]
| Seoul National University Hospital | Seoul, Korea, Republic of, 110-744 Contact: Seok-Chul Yang, MD | scyang@snu.ac.krRecruiting |
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