Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation

Study Overview
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Brief Summary
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As reported, about 0.43% patients can not be intubated unevenly because of difficult airway and 30% of the total death of anesthesia due to failed intubation. The difficult airway will disturb the clinical treatment and even threaten the patients' life. But the present methods for tracheal intubation during awake intubation can not provided ideal intubation condition. In this study, the investigators will perform topical anesthesia with the nebulized 2% lidocaine at 10L/min oxygen flow rate, and the observer's assessment of alert and sedation (OAA/S) scale was controlled to 3-4 points by intravenous midazolam,propofol, and remifentanil. Tracheal intubation was performed after topical anesthesia. The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood samples were taken to measure stress factor during intubation period.Intubation condition score was assessed and the complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation. The investigators aim is to evaluate the effect of topical anesthesia with lidocaine nebulized by 10L/min oxygen flow rate during awake tracheal intubation.

Detailed Description
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90 adult patients for elective surgery under general anesthesia, aged 18-60 years old, Mallampti Ⅰ-Ⅱ class, , were randomly allocated to receive topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times(each group n=30). Before topical anesthesia, the observer's assessment of alert and sedation (OAA/S) scale was controlled to 3-4 points by intravenous midazolam (0.03mg/kg), propofol (2mg/kg/h) and remifentanil (0.05μg/kg/min). Ten minutes after sedation, topical anesthesia was performed with the nebulized 2% lidocaine at 10L/min oxygen flow rate, meantime patients were told to breathe deeply. Tracheal intubation was performed after topical anesthesia. The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood samples were taken to measure the serum cortisol and insulin concentration during intubation period. Intubation condition score was assessed and the complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation.

Official Title
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Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation

Conditions
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Difficult Airway

Intervention / Treatment
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* Procedure: times of topical anesthesia for glottis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients aged 18-60 years old with Mallampti Ⅰ-Ⅱ class Exclusion Criteria: Patients who have allergic reaction to the drugs used during anesthesia Patients who have a history of gastro-esophageal regurgitation, or with full stomach Patients with abnormality of cardiopulmonary function, renal and liver function Patients with abnormality of endocrine function Patients with increased intracranial pressure or epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 times topical anesthesia for glottis<br> | Procedure: times of topical anesthesia for glottis<br>* topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times<br>* Other names: topical anesthesia;|
| Active Comparator: 3 times topical anesthesia for glottis<br> | Procedure: times of topical anesthesia for glottis<br>* topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times<br>* Other names: topical anesthesia;|
| Active Comparator: 4 times topical anesthesia for glottis<br> | Procedure: times of topical anesthesia for glottis<br>* topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times<br>* Other names: topical anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation condition score during awake intubation period | Intubating condition score (Jaw relaxation; Laryngoscopy insertion; Vocal cord position; Coughing; Limb movement; Cuff response) | one years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress factor during intubation period | Blood samples were drawn to measure the serum cortisol and insulin concentration. | one year | 
| Life signs during intubation period | The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded. | one year | 
| The complications during intubation period | The complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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topical anesthesia, tracheal intubation, difficult airway