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

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Difficult Airway

Treatments

Procedure: times of topical anesthesia for glottis

Study type

Interventional

Funder types

Other

Identifiers

NCT01185535
20081110362101197410300047

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 3 patient groups

2 times topical anesthesia for glottis
Active Comparator group
Treatment:
Procedure: times of topical anesthesia for glottis
3 times topical anesthesia for glottis
Active Comparator group
Treatment:
Procedure: times of topical anesthesia for glottis
4 times topical anesthesia for glottis
Active Comparator group
Treatment:
Procedure: times of topical anesthesia for glottis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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