Patient Satisfaction for BronchoscopyPhase 4NCT01121055
Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy
A Phase 4 study testing Lorazepam in people with Patient Satisfaction for Bronchoscopy, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction for Bronchoscopy
- What is being tested?
- Lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged 18 years or older) admitted to the Respiratory Department
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Jong Sun Park, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Seok-Chul Yang, MD, scyang@snu.ac.kr
Jong Sun Park, MD, jspark.im@gmail.com
About 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.
Read the 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.
- Conditions
- Patient Satisfaction for Bronchoscopy
- Being tested
- Lorazepam, Control
- Keywords
- Fiberoptic Bronchoscopy, Patient, Satisfaction, Lorazepam
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorazepamDrug
Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB
ControlDrug
Placebo 1T po at night one day before FB and placebo 1T po 30min before the FB
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB Receives: Drug: Control |
| Lorazepam | Experimental | Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB Receives: Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Measured: within 24 hr of bronchoscopy
Secondary outcomes (1)
relationship between patient satisfaction and sleep quality, anxiety level
Measured: 24hr before and after bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Satisfaction for BronchoscopyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Seok-Chul Yang, MD, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121055
- Sponsor's protocol ID
- Lorazepam in FB
- Status last verified
- May 2010
- First submitted
- 9 May 2010
- Last updated
- 31 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy
- ClinicalTrials.gov ID
- NCT01121055
- Acronym / sponsor ID
- Lorazepam in FB
- Conditions
- Patient Satisfaction for Bronchoscopy
- Keywords
- Fiberoptic Bronchoscopy, Patient, Satisfaction, Lorazepam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: ControlPlacebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB |
| Lorazepam | Experimental | Drug: LorazepamLorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (aged 18 years or older) admitted to the Respiratory Department
Key exclusion criteria (6 listed)
- outpatient procedures
- therapeutic bronchoscopy
- expected operation or discharge within 24 hours after the FB
- sedative premedication
- endotracheal intubation with mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorazepamLorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB | Drug | Lorazepam |
| ControlPlacebo 1T po at night one day before FB and placebo 1T po 30min before the FB | Drug | Control |
Primary outcome
patient satisfaction
Time frame: within 24 hr of bronchoscopy
1 secondary outcome
relationship between patient satisfaction and sleep quality, anxiety level
Time frame: 24hr before and after bronchoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Sun Park, MD contact
Seok-Chul Yang, MD 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lorazepam in people with Patient Satisfaction for Bronchoscopy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seok-Chul Yang, MD, PhD (+82-2-2072-0354, scyang@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: within 24 hr of bronchoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2010.