Syncope, VasovagalNCT00465439
Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal
A study testing Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine in people with Syncope, Vasovagal and Pain Intensity, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
This randomized controlled trial will examine the impact of local anesthetic on the frequency of vasovagal reactions and the patients perception of pain during femoral arterial sheath removal after percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Syncope, Vasovagal, Pain Intensity
- What is being tested?
- Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine
- Type of treatment
- Injection or infusion
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Sep 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Percutaneous Coronary Intervention
- Femoral arterial sheath
Who cannot join
- Less than 18 years old
- Emergency procedure
- Transferred out of heart investigation unit prior to sheath removal
- Radial or brachial sheath
- Closure devise
- Venous sheath insitu
Show all 12Show fewer
- Intra-aortic balloon pump insitu
- Tranvenous pacing
- Mechanical ventilation
- Cognitive impairment
- Unable to read English
- Lidocaine allergy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton Health Science-Heart Investigation Unit
Hamilton, Ontario, L8N 2S2
About this study
Official title: Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal.
This randomized controlled trial will examine the impact of local anesthetic on the frequency of vasovagal reactions and the patients perception of pain during femoral arterial sheath removal after percutaneous coronary intervention.
Read the detailed description
Patients undergoing percutaneous coronary intervention(PCI) will be randomized to receive subcutaneous local anesthetic (Lidocaine 2% without epinephrine)or no local prior to removal of femoral arterial sheath. They will be assessed for vasovagal reactions and pain intensity during the sheath removal.The incidence of vasovagal reactions and pain intensity scores will be compared between the groups. 200 patients will be enrolled over the course of 2 months.
- Conditions
- Syncope, Vasovagal, Pain Intensity
- Being tested
- Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine
- Keywords
- femoral artery sheath, vasovagal reaction, pain, perception
- Medical subject headings
- Syncope, Vasovagal, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous Lidocaine 2% (Xylocaine) without epinephrineDrug
Also called Xylocaine 2% without epinephrine
10 ml subcutaneously
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vasovagal reaction during femoral sheath removal
Measured: During sheath removal
Pain intensity during femoral sheath removal
Measured: During sheath removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syncope, VasovagalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Allison Cook, BScN, Principal investigator, Hamilton Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465439
- Sponsor's protocol ID
- 27071995
- Status last verified
- Aug 2008
- First submitted
- 23 Apr 2007
- Last updated
- 22 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal.
- ClinicalTrials.gov ID
- NCT00465439
- Acronym / sponsor ID
- 27071995
- Conditions
- Syncope, Vasovagal, Pain Intensity
- Keywords
- femoral artery sheath, vasovagal reaction, pain, perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 25 Apr 2007 (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.
This randomized controlled trial will examine the impact of local anesthetic on the frequency of vasovagal reactions and the patients perception of pain during femoral arterial sheath removal after percutaneous coronary intervention.
Detailed description
Patients undergoing percutaneous coronary intervention(PCI) will be randomized to receive subcutaneous local anesthetic (Lidocaine 2% without epinephrine)or no local prior to removal of femoral arterial sheath. They will be assessed for vasovagal reactions and pain intensity during the sheath removal.The incidence of vasovagal reactions and pain intensity scores will be compared between the groups. 200 patients will be enrolled over the course of 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Percutaneous Coronary Intervention
- Femoral arterial sheath
Key exclusion criteria (12 listed)
- Less than 18 years old
- Emergency procedure
- Transferred out of heart investigation unit prior to sheath removal
- Radial or brachial sheath
- Closure devise
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 |
|---|---|---|
| Subcutaneous Lidocaine 2% (Xylocaine) without epinephrineAlso: Xylocaine 2% without epinephrine10 ml subcutaneously | Drug | – |
Primary outcome
Incidence of vasovagal reaction during femoral sheath removal
Time frame: During sheath removal
Pain intensity during femoral sheath removal
Time frame: During sheath removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2008.
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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.
Allison Cook, BScN principal investigator
Hamilton Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine in people with Syncope, Vasovagal and Pain Intensity, run by Hamilton Health Sciences Corporation 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 22 Aug 2008. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of vasovagal reaction during femoral sheath removal (time frame: During sheath removal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2008.