Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy - Tabular View

Tracking Information

First Received Date ^ICMJE

October 31, 2006

Last Updated Date

June 4, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Heart Rate
Systolic Blood Pressure
Diastolic Blood Pressure
Rate pressure product (HR*SBP/100)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00394537 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy

Official Title ^ICMJE

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Bronchoscopy

Intervention ^ICMJE

Drug: Labetalol 10mg iv

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00394537

Responsible Party

Study ID Numbers ^ICMJE

3997

Study Sponsor ^ICMJE

Rabin Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Mordechai Kramer, MD

Rabin Medical Center

Information Provided By

Rabin Medical Center

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP