Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy

Bronchoscopy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394537
• Other study ID #: 3997
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2006
• Last updated: June 4, 2007
• Est. completion date: May 2007

Study information

• Verified date: May 2007
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Passing a bronchoscope through the airways frequently causes a stress response even though patients are sedated. This stress response is usually an increase in pulse and blood pressure, which may have undesirable effects on the heart and circulation.

We plan to give patients labetalol (a beta blocker which reduces pulse and blood pressure) in addition to normal sedation, to patients undergoing bronchoscopy in our department.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients over 18 years old undergo fiberoptic bronchoscopy in our unit

Exclusion Criteria:

• inability or refusal to give informed consent

• bronchoscopy through an artificial airway

• intolerance or allergy to the study drug

• bradycardia (HR<60/min) or hypotension (systolic BP <100) at screening

• pregnancy,

• concomitant treatment with diltiazem or verapamil

• intention to use propofol as the sedative agent for bronchoscopy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchoscopy

Intervention

Drug:
• Labetalol 10mg iv

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate
Primary	Systolic Blood Pressure
Primary	Diastolic Blood Pressure
Primary	Rate pressure product (HR*SBP/100)