Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy

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

Tracking Information

• First Submitted Date: October 31, 2006
• First Posted Date: November 1, 2006
• Last Update Posted Date: June 6, 2007
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: October 31, 2006)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Bronchoscopy
• Intervention: Drug: Labetalol 10mg iv
• Study Arms: 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: October 31, 2006): 72
• Original Enrollment: Same as current
• Actual Study Completion Date: May 2007
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00394537
• Other Study ID Numbers: 3997
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Rabin Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mordechai Kramer, MD; Rabin Medical Center

• PRS Account: Rabin Medical Center
• Verification Date: May 2007