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

Difficult Airway Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01185535
• Other study ID #: 20081110362101197410300047
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: July 26, 2010
• Last updated: August 19, 2010
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adult patients aged 18-60 years old with Mallampti ?-? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Difficult Airway

Intervention

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

Locations

Country	Name	City	State
China	lab of The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation condition score during awake intubation period	Intubating condition score (Jaw relaxation; Laryngoscopy insertion; Vocal cord position; Coughing; Limb movement; Cuff response)	one years	Yes
Secondary	Stress factor during intubation period	Blood samples were drawn to measure the serum cortisol and insulin concentration.	one year	Yes
Secondary	Life signs during intubation period	The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded.	one year	Yes
Secondary	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	Yes

External Links

•   PUMED