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

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.

Study Overview

• Status: Unknown
• Conditions: Difficult Airway
• Intervention / Treatment: Procedure: times of topical anesthesia for glottis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • lab of The Sixth Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: topical anesthesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Publications and helpful links

General Publications

• Jiang H, Miao HS, Jin SQ, Chen LH, Tian JL. A pilot study of the effect of pressure-driven lidocaine spray on airway topical anesthesia for conscious sedation intubation. Chin Med J (Engl). 2011 Dec;124(23):3997-4001.

Helpful Links

• PUMED

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ANTICIPATED): August 1, 2010
• Study Completion (ANTICIPATED): December 1, 2010

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: August 19, 2010
• First Posted (ESTIMATE): August 20, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 20, 2010
• Last Update Submitted That Met QC Criteria: August 19, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: difficult airway; tracheal intubation; topical anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 20081110362101197410300047