NCT00394537

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

June 6, 2007

Status Verified

May 1, 2007

First QC Date

October 31, 2006

Last Update Submit

June 4, 2007

Conditions

Bronchoscopy

Outcome Measures

Primary Outcomes (4)

  • Heart Rate

  • Systolic Blood Pressure

  • Diastolic Blood Pressure

  • Rate pressure product (HR*SBP/100)

Interventions

Labetalol 10mg ivDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients over 18 years old undergo fiberoptic bronchoscopy in our unit

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Related Publications (1)

  • 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.

    PMID: 18394874DERIVED

MeSH Terms

Interventions

Labetalol

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAmines

Study Officials

  • Mordechai Kramer, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 1, 2006

Study Completion

May 1, 2007

Last Updated

June 6, 2007

Record last verified: 2007-05

Locations

IL(1)