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Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00394537
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : June 6, 2007
Sponsor:
Information provided by:
Rabin Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Bronchoscopy Drug: Labetalol 10mg iv Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Labetalol

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Heart Rate
  2. Systolic Blood Pressure
  3. Diastolic Blood Pressure
  4. Rate pressure product (HR*SBP/100)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394537


Locations
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Israel
Rabin Medical Center
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Mordechai Kramer, MD Rabin Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00394537    
Other Study ID Numbers: 3997
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: June 6, 2007
Last Verified: May 2007
Additional relevant MeSH terms:
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Labetalol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
 Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists