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Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy

NCT ID: NCT00394537

Last Updated: 2007-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2007-05-31

Brief Summary

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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

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Conditions

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Bronchoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Labetalol 10mg iv

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Mordechai Kramer, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 18394874 (View on PubMed)

Other Identifiers

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3997

Identifier Type: -

Identifier Source: org_study_id