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

NCT01185535 | Unknown Phase 2 DMC

• 1 other identifier: 20081110362101197410300047
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Difficult Airway

Keywords

topical anesthesia; tracheal intubation; difficult airway

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Stress factor during intubation period

  one year

• Life signs during intubation period

  one year

• The complications during intubation period

  one year

Study Arms (3)

2 times topical anesthesia for glottis

ACTIVE COMPARATOR

Procedure: times of topical anesthesia for glottis

3 times topical anesthesia for glottis

ACTIVE COMPARATOR

Procedure: times of topical anesthesia for glottis

4 times topical anesthesia for glottis

ACTIVE COMPARATOR

Procedure: times of topical anesthesia for glottis

Interventions

times of topical anesthesia for glottis PROCEDURE

topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times

Also known as: topical anesthesia

2 times topical anesthesia for glottis; 3 times topical anesthesia for glottis; 4 times topical anesthesia for glottis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 18-60 years old with Mallampti Ⅰ-Ⅱ class

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

lab of The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (1)

• 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.

  PMID: 22340331 DERIVED

Related Links

• PUMED

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Jin s qing, doctor

  Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: August 20, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 20, 2010

Record last verified: 2010-04

Locations

CN (1)