Glossopharyngeal Nerve Block for Awake Intubation

NCT01790464 | Completed

• 1 other identifier: 11-201-SDR
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endotracheal intubation of the morbidly obese is often performed awake. This is performed after topical anesthesia of the patient's pharynx and larynx. There are many techniques used to perform topical anesthesia of the patient's airway, which include aerosolization of local anesthesia, topical application of local anesthesia, and nerve blockade using needles and local anesthesia. Reasons for failure of any awake tracheal intubation technique is excess gagging. The most effective method to adequately anesthetize the airway to decrease the amount of gagging is unknown. The investigators wish to assess if the instillation of local anesthesia soaked gauze next to the peritonsillar pillars will decrease the number of gagging episodes during awake video laryngoscopy assisted tracheal intubation of the morbidly obese.

Conditions

Morbid Obesity

Keywords

Glossopharyngeal nerve block; Airway anesthesia; Awake intubation

Outcome Measures

Primary Outcomes (1)

• Gag score

  We wish to assess if the instillation of local anesthesia soaked gauze next to the peritonsillar pillars will decrease the number of gagging episodes during awake video laryngoscopy assisted tracheal intubation of the morbidly obese.

  10 minutes

Secondary Outcomes (1)

• Lidocaine serum level

  40 minutes

Study Arms (2)

NS gauze

PLACEBO COMPARATOR

Standard airway anesthesia with 20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked in normal saline (Control Group)

Drug: placebo

Lidocaine gauze

ACTIVE COMPARATOR

20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked with 2% lidocaine (Glossopharyngeal Group).

Drug: 2% Lidocaine

Interventions

2% Lidocaine DRUG

2% lidocaine and peritonsillar instillation of gauze soaked with 2% lidocaine (Glossopharyngeal Group).

Lidocaine gauze

placebo DRUG

NS gauze

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All morbidly obese patient presenting for bariatric surgery at the Royal Victoria Hospital are eligible.

You may not qualify if:

• moderate to severe systemic illness, i.e. American Society of Anesthesiologists (ASA) score of 4 or higher
• inability to communicate in English or French
• contraindications to the drugs used in the study

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 13, 2013
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: April 1, 2014
• Last Updated: September 17, 2014

Record last verified: 2014-09