Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Difficult Airway |
Procedure: times of topical anesthesia for glottis |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation |
- Intubation condition score during awake intubation period [ Time Frame: one years ] [ Designated as safety issue: Yes ]Intubating condition score (Jaw relaxation; Laryngoscopy insertion; Vocal cord position; Coughing; Limb movement; Cuff response)
- Stress factor during intubation period [ Time Frame: one year ] [ Designated as safety issue: Yes ]Blood samples were drawn to measure the serum cortisol and insulin concentration.
- Life signs during intubation period [ Time Frame: one year ] [ Designated as safety issue: Yes ]The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded.
- The complications during intubation period [ Time Frame: one year ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 90 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 2 times topical anesthesia for glottis |
Procedure: times of topical anesthesia for glottis
topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times
Other Name: topical anesthesia
|
| Active Comparator: 3 times topical anesthesia for glottis |
Procedure: times of topical anesthesia for glottis
topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times
Other Name: topical anesthesia
|
| Active Comparator: 4 times topical anesthesia for glottis |
Procedure: times of topical anesthesia for glottis
topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times
Other Name: topical anesthesia
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| China, Guangdong | |
| lab of The Sixth Affiliated Hospital, Sun Yat-sen University | |
| Guangzhou, Guangdong, China, 510655 | |
| Study Director: | Jin s qing, doctor | the Sixth Affiliated Hospital of Sun Yat-sen University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Guangdong Science Committee |
| ClinicalTrials.gov Identifier: | NCT01185535 History of Changes |
| Other Study ID Numbers: | 20081110362101197410300047 |
| Study First Received: | July 26, 2010 |
| Last Updated: | August 19, 2010 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Sun Yat-sen University:
|
topical anesthesia tracheal intubation difficult airway |
Additional relevant MeSH terms:
|
Anesthetics Lidocaine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013