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The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery

The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00852410
Enrollment
140
Registered
2009-02-27
Start date
2009-03-31
Completion date
2010-04-30
Last updated
2010-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Sinusitis

Keywords

Endoscopic sinus surgery

Brief summary

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.

Interventions

DRUG1% lidocaine with 1:100,000 adrenaline

high dose

DRUG1% lidocaine with 1:200,000 adrenaline

1% lidocaine with 1:200,000 adrenaline

Sponsors

University of Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Reduction of Intraoperative bleedingduring surgery

Secondary

MeasureTime frame
hemodynamic fluctuationduring surgery

Countries

Canada

Contacts

Primary ContactAli Moshaver, MD
moshaver@yahoo.com250-276-5050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026