Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy

This study has been completed.

First Received on October 31, 2006. Last Updated on June 4, 2007 History of Changes

Sponsor:	Rabin Medical Center
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00394537

Purpose

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.

Condition	Intervention	Phase
Bronchoscopy	Drug: Labetalol 10mg iv	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Labetalol hydrochloride Labetalol Dilevalol

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:

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

Estimated Enrollment:	72
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394537

Locations

Israel
Rabin Medical Center
Petach Tikva, Israel, 49100

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator:

Mordechai Kramer, MD

Rabin Medical Center

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00394537 History of Changes
Other Study ID Numbers:	3997
Study First Received:	October 31, 2006
Last Updated:	June 4, 2007
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Labetalol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists

ClinicalTrials.gov processed this record on February 13, 2012