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.
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:
- No reaction
- Single change in facial expression
- Grimacing facial expression
- Severe facial grimace, no reflex head movements
- Severe facial grimace with head movements
- 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 group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: placebo |
| Lidocaine gauze | Active comparator | 20 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.
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)
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.
- First posted13 Feb 2013 (estimated)
- Study startApr 2012
- Primary completionJun 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Moore, McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glossopharyngeal Nerve Blockade for Awake Videolaryngoscopy Assisted Endotracheal Intubation in the Morbidly Obese
- ClinicalTrials.gov ID
- NCT01790464
- Acronym / sponsor ID
- 11-201-SDR
- Conditions
- Morbid Obesity
- Keywords
- Glossopharyngeal nerve block, Airway anesthesia, Awake intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- No reaction
- Single change in facial expression
- Grimacing facial expression
- Severe facial grimace, no reflex head movements
- Severe facial grimace with head movements
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NS gauze | Placebo comparator | Drug: placeboStandard airway anesthesia with 20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked in normal saline (Control Group) |
| Lidocaine gauze | Active comparator | Drug: 2% Lidocaine20 ml of aerosolized 2% lidocaine and peritonsillar instillation of gauze soaked with 2% lidocaine (Glossopharyngeal Group). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All morbidly obese patient presenting for bariatric surgery at the Royal Victoria Hospital are eligible.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% Lidocaine2% lidocaine and peritonsillar instillation of gauze soaked with 2% lidocaine (Glossopharyngeal Group). | Drug | Lidocaine gauze |
| placebo | Drug | NS gauze |
Primary outcome
Gag score
Time frame: 10 minutes
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.
1 secondary outcome
Lidocaine serum level
Time frame: 40 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
Related trials for Morbid Obesity
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.