Glossopharyngeal Nerve Blockade for Awake Videolaryngosco... | NCT01791439

Studies
Glossopharyngeal Nerve Blockade for Awake Videolaryngoscope Assisted Endotracheal Intubation in the Morbidly Obese

NCT01791439

Sponsor

Royal Victoria Hospital, Canada

Status

Unknown status

Last Update Posted

Feb 15, 2013Estimated

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Gagging

Interventions

lidocaine
placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
11-201-SDR	Other Identifier	research ethics office

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Apr 2013Estimated

Completion Date

Not provided

First Submitted Date

Feb 10, 2013

First Submission Date that Met QC Criteria

Feb 13, 2013

First Posted Date

Feb 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2013

Last Update Posted Date

Feb 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lidocaine	Experimental	Patients in this arm will have gauze soaked with lidocaine applied to the peritonsillar pillars.	Other: lidocaine
Saline	Placebo Comparator	Application of saline to the glossopharyngeal nerve.	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lidocaine	Other	Application of lidocaine to the glossopharyngeal nerve.	Lidocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gagging	We will assess the amount of gagging during the awake intubation.	2 minutes

Secondary Outcomes

Measure	Description	Time Frame
vital signs	we will asses vital signs during intubation.	2 minutes
lidocaine levels		40 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Albert Moore, md	Contact	5149341934	34880	moore_albert@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Victoria Hospital	Recruiting	Montreal	Quebec	H3A1A1	Canada

Condition Browse Module

MeSH Terms

ID	Term
D005683	Gagging

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided