Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy

Condition(s) targeted: Bronchoscopy

Intervention: Labetalol 10mg iv (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Mordechai Kramer, MD, Principal Investigator, Affiliation: Rabin Medical Center

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.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Heart Rate

Systolic Blood Pressure

Diastolic Blood Pressure

Rate pressure product (HR*SBP/100)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Rabin Medical Center, Petach Tikva 49100, Israel

Ending date: May 2007
Last updated: June 4, 2007