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The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery

NCT ID: NCT00852410

Last Updated: 2010-06-30

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-04-30

Brief Summary

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Obtaining adequate hemostasis is crucial during endoscopic sinus surgery. Submucosal injection of local anaesthetic containing adrenaline has frequently been used to improve surgical milieu. However, injection of adrenaline has potential side effects including tachycardia, hypertension as well as inducing arrhythmia. The aim of this randomized clinical trial is to assess the hemodynamic and hemostatic effects of two different concentrations of adrenaline in local anaesthetic used during endoscopic sinus surgery.

Detailed Description

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Conditions

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Chronic Sinusitis

Keywords

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Endoscopic sinus surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1% lidocaine with 1:100000 adrenaline

high dose adrenaline

Group Type ACTIVE_COMPARATOR

1% lidocaine with 1:100,000 adrenaline

Intervention Type DRUG

high dose

1% lidocaine with 1:200,000 adrenaline

low dose

Group Type ACTIVE_COMPARATOR

1% lidocaine with 1:200,000 adrenaline

Intervention Type DRUG

1% lidocaine with 1:200,000 adrenaline

Interventions

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1% lidocaine with 1:100,000 adrenaline

high dose

Intervention Type DRUG

1% lidocaine with 1:200,000 adrenaline

1% lidocaine with 1:200,000 adrenaline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* recurrent acute sinusitis, chronic sinusitis, or nasal polyposis

Exclusion Criteria

* bleeding disorders, under age of 18, history of cardiac disease or on antihypertensive medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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University Of Toronto

Principal Investigators

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Ali Moshaver, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Ali Moshaver, MD

Role: CONTACT

Phone: 250-276-5050

Email: [email protected]

Facility Contacts

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Ali Moshaver, MD

Role: primary

References

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Moshaver A, Lin D, Pinto R, Witterick IJ. The hemostatic and hemodynamic effects of epinephrine during endoscopic sinus surgery: a randomized clinical trial. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):1005-9. doi: 10.1001/archoto.2009.144.

Reference Type DERIVED
PMID: 19841339 (View on PubMed)

Other Identifiers

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09-0001-A

Identifier Type: -

Identifier Source: org_study_id