GaggingNCT01791439
Glossopharyngeal Nerve Blockade for Awake Videolaryngoscope Assisted Endotracheal Intubation in the Morbidly Obese
A study testing lidocaine in people with Gagging, run by Royal Victoria Hospital, Canada at 1 site in Canada.
Trial summary
The investigators wish to determine if application of 2% lidocaine soaked gauze to the peritonsillar pillars will decrease the amount of gagging caused by awake videolaryngocope assisted tracheal intubation in the morbidly obese. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gagging
- What is being tested?
- lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Apr 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- morbid obese patients scheduled for bariatric surgery, with a planned awake intubation.
Who cannot join
- inability to communicate in English or french
- allergies to any study drugs
- any patient with an American society of anesthesiologists score of 4 or more
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal Victoria Hospital
Montreal, Quebec, H3A1A1
Albert Moore, MD, 5149341934 ext. 34880, moore_albert@hotmail.com
About this study
Official title: Glossopharyngeal Nerve Blockade for Awake Videolaryngoscope Assisted Endotracheal Intubation in the Morbidly Obese.
The investigators wish to determine if application of 2% lidocaine soaked gauze to the peritonsillar pillars will decrease the amount of gagging caused by awake videolaryngocope assisted tracheal intubation in the morbidly obese.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineOther
Application of lidocaine to the glossopharyngeal nerve.
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Patients in this arm will have gauze soaked with lidocaine applied to the peritonsillar pillars. Receives: Other: lidocaine |
| Saline | Placebo comparator | Application of saline to the glossopharyngeal nerve. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gagging
We will assess the amount of gagging during the awake intubation.
Measured: 2 minutes
Secondary outcomes (2)
vital signs
we will asses vital signs during intubation.
Measured: 2 minutes
lidocaine levels
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaggingStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Victoria Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Moore, Royal Victoria Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791439
- Sponsor's protocol ID
- 11-201-SDR
- Other IDs
- 11-201-SDR
- Status last verified
- Feb 2013
- First submitted
- 10 Feb 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glossopharyngeal Nerve Blockade for Awake Videolaryngoscope Assisted Endotracheal Intubation in the Morbidly Obese.
- ClinicalTrials.gov ID
- NCT01791439
- Acronym / sponsor ID
- 11-201-SDR
- Conditions
- Gagging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Royal Victoria Hospital, CanadaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (estimated)
- First posted
- 15 Feb 2013 (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.
The investigators wish to determine if application of 2% lidocaine soaked gauze to the peritonsillar pillars will decrease the amount of gagging caused by awake videolaryngocope assisted tracheal intubation in the morbidly obese.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Other: lidocainePatients in this arm will have gauze soaked with lidocaine applied to the peritonsillar pillars. |
| Saline | Placebo comparator | Other: placeboApplication of saline to the glossopharyngeal nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- morbid obese patients scheduled for bariatric surgery, with a planned awake intubation.
Key exclusion criteria (3 listed)
- inability to communicate in English or french
- allergies to any study drugs
- any patient with an American society of anesthesiologists score of 4 or more
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 |
|---|---|---|
| lidocaineApplication of lidocaine to the glossopharyngeal nerve. | Other | Lidocaine |
| placebo | Other | Saline |
Primary outcome
Gagging
Time frame: 2 minutes
We will assess the amount of gagging during the awake intubation.
2 secondary outcomes
vital signs
Time frame: 2 minutes
lidocaine levels
Time frame: 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lidocaine in people with Gagging, run by Royal Victoria Hospital, Canada 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 3 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 15 Feb 2013. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert Moore, md (5149341934 ext. 34880, moore_albert@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gagging (time frame: 2 minutes). 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 15 Feb 2013.