Effect of Additive Lorazepam on Patient Satisfaction as a... | NCT01121055

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

NCT01121055

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

May 31, 2010Estimated

Enrollment

372Estimated

Phase

Phase 4

Conditions

Patient Satisfaction for Bronchoscopy

Interventions

Lorazepam
Control

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Aug 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

May 9, 2010

First Submission Date that Met QC Criteria

May 9, 2010

First Posted Date

May 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2010

Last Update Posted Date

May 31, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

372Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	Placebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB	Drug: Control
Lorazepam	Experimental	Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB	Drug: Lorazepam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lorazepam	Drug	Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB	Lorazepam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient satisfaction		within 24 hr of bronchoscopy

Secondary Outcomes

Measure	Description	Time Frame
relationship between patient satisfaction and sleep quality, anxiety level		24hr before and after bronchoscopy

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seok-Chul Yang, MD, PhD	Contact	+82-2-2072-0354		scyang@snu.ac.kr
Jong Sun Park, MD	Contact			jspark.im@gmail.com

Overall Officials

Name	Affiliation	Role
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	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-744	South Korea

ID	Term
D010549	Personal Satisfaction

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D008140	Lorazepam

Ancestor Terms

ID	Term
D001570	Benzodiazepinones
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided