NCT01791439

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

3 months

First QC Date

February 10, 2013

Last Update Submit

February 13, 2013

Conditions

Gagging

Outcome Measures

Primary Outcomes (1)

  • Gagging

    We will assess the amount of gagging during the awake intubation.

    2 minutes

Secondary Outcomes (2)

  • vital signs

    2 minutes

  • lidocaine levels

    40 minutes

Study Arms (2)

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

lidocaineOTHER

Application of lidocaine to the glossopharyngeal nerve.

Lidocaine
placeboOTHER
Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • morbid obese patients scheduled for bariatric surgery, with a planned awake intubation.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A1A1, Canada

RECRUITING

MeSH Terms

Conditions

Gagging

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Albert Moore, md

CONTACT

5149341934moore_albert@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 10, 2013

First Posted

February 15, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

CA(1)