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Morbid ObesityNCT01790464

Glossopharyngeal Nerve Block for Awake Intubation

A study testing 2% Lidocaine in people with Morbid Obesity, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Morbid Obesity
What is being tested?
2% Lidocaine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
No sites listed yet
Study dates
Apr 2012to Apr 2014
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

About this study

Official title: Glossopharyngeal Nerve Blockade for Awake Videolaryngoscopy Assisted Endotracheal Intubation in the Morbidly Obese

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.

Read the detailed description

Research design 1.1 Study design Prospective randomized control trial. 1.2 Patients All morbidly obese patient presenting for bariatric surgery at the Royal Victoria Hospital are eligible.

1.3 Exclusions We will exclude any patient with

  • 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 1.4 Recruitment Eligible patients admitted to Royal Victoria Hospital who do not have any of the exclusion criteria will be approached by one of the investigators in the recovery room, or in the preoperative clinic before the scheduled surgery. The study protocol will be explained and a consent form will be given to the patients. Patients will have time and opportunity to ask any questions before the consent will be signed.

1.5 Study protocol Patients will be prepared for surgery according to the routine guidelines established by the Departments of Surgery and Anesthesia at the Royal Victoria Hospital.

They will have an IV and peripheral arterial line inserted, and will have Canadian Anesthesia Society standard monitors placed. Glycopyrrolate 0.4 mg iv will be given to decrease secretions. Using a computer generated randomization table, patients will be assigned to a group that receives standard airway anesthesia with 20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked in normal saline (Control Group) or that receives 20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked with 2% lidocaine (Glossopharyngeal Group). Sedation will be administered using a remifentanyl intravenous infusion of 0.05 /min with an initial bolus of 0.4µg/kg, and intravenous midazolam 0.05 mg/kg. We will review the chart to obtain patient demographic data including patient age, height, weight, medications, and past medical histories. Baseline blood pressure, heart rate, will be recorded, and a blood sample will be drawn for lidocaine level.

Once the airway is topicalized and sedation has taken effect, the anesthesiologist will insert the video laryngoscope into the patient's oropharynx. Once the ideal view of the vocal cords is obtained, an endotracheal tube fitted with a stylet will be introduced into the pharynx, and then slid through the vocal cords into the trachea. During the intubation attempt, a blinded observer will record the blood pressure and heart rate at every minute, and the best view obtained with the laryngoscope. The observer will assign the patient a reaction score (4) at three time points: the insertion of the video laryngoscope, the pharyngeal insertion of the tracheal tube, and the tracheal insertion of the tracheal tube. This score will be:

  1. No reaction
  2. Single change in facial expression
  3. Grimacing facial expression
  4. Severe facial grimace, no reflex head movements
  5. Severe facial grimace with head movements
  6. Severe facial grimace with head and limb movements The observer will also record the time from the insertion of the video laryngoscope, and the first evidence of endtidal carbon dioxide from the tracheal tube. If the intubation attempt results in a reaction score of 6, or in an inadequate laryngeal view, the treating anesthesiologist may secure the airway in any way they see fit, which may include addition of more topical anesthesia, more sedation, or the use of another airway technique. The number of attempts at intubation, and any other techniques used for intubation will be recorded. We will measure lidocaine levels in blood samples every 10 minutes for 40 minutes after the commencement of the airway anesthesia, using the mass spectrometry method previously used for similar studies at the Royal Victoria Hospital.
Conditions
Morbid Obesity
Being tested
2% Lidocaine, placebo
Keywords
Glossopharyngeal nerve block, Airway anesthesia, Awake intubation
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2% LidocaineDrug

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

  • placeboDrug

Study groups in NCT01790464
Study groupRoleWhat they receive
NS gauzePlacebo comparatorStandard airway anesthesia with 20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked in normal saline (Control Group)
Receives: Drug: placebo
Lidocaine gauzeActive comparator20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked with 2% lidocaine (Glossopharyngeal Group).
Receives: Drug: 2% Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 10 minutes

Secondary outcomes (1)
  1. Lidocaine serum level

    Level of lidocaine in patients serum at 10, 20, 30 and 40 minutes post chewing.

    Measured: 40 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2013 (estimated)
  2. Study startApr 2012
  3. Primary completionJun 2013
  4. Study completionApr 2014

Resources

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
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01790464
Sponsor's protocol ID
11-201-SDR
Status last verified
Sep 2014
First submitted
11 Feb 2013
Last updated
17 Sep 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing 2% Lidocaine in people with Morbid Obesity, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.

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: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gag score (time frame: 10 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 17 Sep 2014.

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Glossopharyngeal Nerve Block for Awake Intubation | AzTrials