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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01121055
First received: May 9, 2010
Last updated: May 27, 2010
Last verified: May 2010
History of Changes
  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.


Condition Intervention Phase
Patient Satisfaction for Bronchoscopy
 Drug: Lorazepam
Drug: Control
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
Drug Information available for: Lorazepam
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • patient satisfaction [ Time Frame: within 24 hr of bronchoscopy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • relationship between patient satisfaction and sleep quality, anxiety level [ Time Frame: 24hr before and after bronchoscopy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 372
Study Start Date: March 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Placebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB
 Drug: Control
Placebo 1T po at night one day before FB and placebo 1T po 30min before the FB
Experimental: Lorazepam
Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB
 Drug: Lorazepam
Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121055

Contacts
Contact: Seok-Chul Yang, MD, PhD +82-2-2072-0354 scyang@snu.ac.kr
Contact: Jong Sun Park, MD jspark.im@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Seok-Chul Yang, MD         scyang@snu.ac.kr    
Contact: Jong Sun Park, MD         jspark.im@gmail.com    
Sponsors and Collaborators
Seoul National University Hospital
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
  More Information

No publications provided

Responsible Party: Seok-Chul Yang, MD, PhD, FCCP, Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
ClinicalTrials.gov Identifier: NCT01121055     History of Changes
Other Study ID Numbers: Lorazepam in FB
Study First Received: May 9, 2010
Last Updated: May 27, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Fiberoptic Bronchoscopy
Patient
Satisfaction
Lorazepam

Additional relevant MeSH terms:
Lorazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
 Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 21, 2013