- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01791439
Glossopharyngeal Nerve Blockade for Awake Videolaryngoscope Assisted Endotracheal Intubation in the Morbidly Obese
February 13, 2013 updated by: Albert Moore, Royal Victoria Hospital, Canada
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Albert Moore, MD
- Phone Number: 34880 5149341934
- Email: moore_albert@hotmail.com
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3A1A1
- Recruiting
- Royal Victoria Hospital
-
Contact:
- Albert Moore, MD
- Phone Number: 34880 5149341934
- Email: moore_albert@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- morbid obese patients scheduled for bariatric surgery, with a planned awake intubation.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lidocaine
Patients in this arm will have gauze soaked with lidocaine applied to the peritonsillar pillars.
|
Application of lidocaine to the glossopharyngeal nerve.
|
Placebo Comparator: Saline
Application of saline to the glossopharyngeal nerve.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gagging
Time Frame: 2 minutes
|
We will assess the amount of gagging during the awake intubation.
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vital signs
Time Frame: 2 minutes
|
we will asses vital signs during intubation.
|
2 minutes
|
lidocaine levels
Time Frame: 40 minutes
|
40 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
April 1, 2013
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
February 10, 2013
First Submitted That Met QC Criteria
February 13, 2013
First Posted (Estimate)
February 15, 2013
Study Record Updates
Last Update Posted (Estimate)
February 15, 2013
Last Update Submitted That Met QC Criteria
February 13, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Gagging
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 11-201-SDR (research ethics office)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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