Labetalol to Prevent Hypertension and Tachycardia During... | NCT00394537

Studies
Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy

NCT00394537

Sponsor

Rabin Medical Center

Status

Completed

Last Update Posted

Jun 6, 2007Estimated

Enrollment

72Estimated

Phase

Phase 4

Conditions

Bronchoscopy

Interventions

Labetalol 10mg iv

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Oct 31, 2006

First Submission Date that Met QC Criteria

Oct 31, 2006

First Posted Date

Nov 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2007

Last Update Posted Date

Jun 6, 2007Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Name	Type	Description	Arm Group Labels	Other Names
Labetalol 10mg iv	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart Rate
Systolic Blood Pressure
Diastolic Blood Pressure
Rate pressure product (HR*SBP/100)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mordechai Kramer, MD	Rabin Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabin Medical Center		Petah Tikva		49100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18394874	Derived	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.

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals