Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy

This study has been completed.
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00394537
First received: October 31, 2006
Last updated: June 4, 2007
Last verified: May 2007
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014