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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Patient Satisfaction for Bronchoscopy

Treatments: Drug: Lorazepam; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01121055

Lorazepam in FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 372 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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372 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Placebo 1T by mouth (po) at night one day before FB and placebo 1T po 30min before the FB

Treatment:

Drug: Control

Lorazepam

Experimental group

Description:

Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB

Treatment:

Drug: Lorazepam