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Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy

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ClinicalTrials.gov Identifier: NCT00394537
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : June 6, 2007
Information provided by:
Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE October 31, 2006
First Posted Date  ICMJE November 1, 2006
Last Update Posted Date June 6, 2007
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
  • Heart Rate
  • Systolic Blood Pressure
  • Diastolic Blood Pressure
  • Rate pressure product (HR*SBP/100)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy
Official Title  ICMJE Not Provided
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Bronchoscopy
Intervention  ICMJE Drug: Labetalol 10mg iv
Study Arms  ICMJE Not Provided
Publications * Fox BD, Krylov Y, Leon P, Ben-Zvi I, Peled N, Shitrit D, Kramer MR. Benzodiazepine and opioid sedation attenuate the sympathetic response to fiberoptic bronchoscopy. Prophylactic labetalol gave no additional benefit. Results of a randomized double-blind placebo-controlled study. Respir Med. 2008 Jul;102(7):978-83. doi: 10.1016/j.rmed.2008.02.011. Epub 2008 Apr 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 31, 2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00394537
Other Study ID Numbers  ICMJE 3997
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rabin Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mordechai Kramer, MD Rabin Medical Center
PRS Account 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