Overview

This trial is active, not recruiting.

Condition difficult airway
Treatment times of topical anesthesia for glottis
Phase phase 2/phase 3
Sponsor Sun Yat-sen University
Start date January 2010
End date August 2010
Trial size 90 participants
Trial identifier NCT01185535, 20081110362101197410300047

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
times of topical anesthesia for glottis topical anesthesia
topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times
(Active Comparator)
times of topical anesthesia for glottis topical anesthesia
topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times
(Active Comparator)
times of topical anesthesia for glottis topical anesthesia
topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times

Primary Outcomes

Measure
Intubation condition score during awake intubation period
time frame: one years

Secondary Outcomes

Measure
Stress factor during intubation period
time frame: one year
Life signs during intubation period
time frame: one year
The complications during intubation period
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.