Chronic SinusitisPhase 3NCT00852410
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery
A Phase 3 study testing 1% lidocaine with 1:100,000 adrenaline and 1% lidocaine with 1:200,000 adrenaline in people with Chronic Sinusitis, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- 1% lidocaine with 1:100,000 adrenaline and 1% lidocaine with 1:200,000 adrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- recurrent acute sinusitis, chronic sinusitis, or nasal polyposis
Who cannot join
- bleeding disorders, under age of 18, history of cardiac disease or on antihypertensive medications
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto
Toronto, Ontario, M6R 1B5
Ali Moshaver, MD, 250-276-5050, moshaver@yahoo.com
Ali Moshaver, MD
About this study
Official title: The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial
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.
- Conditions
- Chronic Sinusitis
- Being tested
- 1% lidocaine with 1:100,000 adrenaline, 1% lidocaine with 1:200,000 adrenaline
- Keywords
- Endoscopic sinus surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% lidocaine with 1:100,000 adrenalineDrug
high dose
1% lidocaine with 1:200,000 adrenalineDrug
1% lidocaine with 1:200,000 adrenaline
| Study group | Role | What they receive |
|---|---|---|
| 1% lidocaine with 1:100000 adrenaline | Active comparator | high dose adrenaline Receives: Drug: 1% lidocaine with 1:100,000 adrenaline |
| 1% lidocaine with 1:200,000 adrenaline | Active comparator | low dose Receives: Drug: 1% lidocaine with 1:200,000 adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Intraoperative bleeding
Measured: during surgery
Secondary outcomes (1)
hemodynamic fluctuation
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Ali Moshaver, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852410
- Sponsor's protocol ID
- 09-0001-A
- Status last verified
- Jun 2010
- First submitted
- 26 Feb 2009
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19841339
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00852410
- Acronym / sponsor ID
- 09-0001-A
- Conditions
- Chronic Sinusitis
- Keywords
- Endoscopic sinus surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1% lidocaine with 1:100000 adrenaline | Active comparator | Drug: 1% lidocaine with 1:100,000 adrenalinehigh dose adrenaline |
| 1% lidocaine with 1:200,000 adrenaline | Active comparator | Drug: 1% lidocaine with 1:200,000 adrenalinelow dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- recurrent acute sinusitis, chronic sinusitis, or nasal polyposis
Key exclusion criteria (1 listed)
- bleeding disorders, under age of 18, history of cardiac disease or on antihypertensive medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% lidocaine with 1:100,000 adrenalinehigh dose | Drug | 1% lidocaine with 1:100000 adrenaline |
| 1% lidocaine with 1:200,000 adrenaline1% lidocaine with 1:200,000 adrenaline | Drug | 1% lidocaine with 1:200,000 adrenaline |
Primary outcome
Reduction of Intraoperative bleeding
Time frame: during surgery
1 secondary outcome
hemodynamic fluctuation
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
- Derived from this study: PubMed 19841339Moshaver 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Moshaver, MD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1% lidocaine with 1:100,000 adrenaline and 1% lidocaine with 1:200,000 adrenaline in people with Chronic Sinusitis, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Moshaver, MD (250-276-5050, moshaver@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Intraoperative bleeding (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00852410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2010.