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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Sun Yat-sen University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01185535
First received: July 26, 2010
Last updated: August 19, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Difficult Airway
Procedure: times of topical anesthesia for glottis
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Intubation condition score during awake intubation period [ Time Frame: one years ] [ Designated as safety issue: Yes ]
    Intubating condition score (Jaw relaxation; Laryngoscopy insertion; Vocal cord position; Coughing; Limb movement; Cuff response)


Secondary Outcome Measures:
  • Stress factor during intubation period [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Blood samples were drawn to measure the serum cortisol and insulin concentration.

  • Life signs during intubation period [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded.

  • The complications during intubation period [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 90
Study Start Date: January 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: topical anesthesia

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185535

Locations
China, Guangdong
lab of The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Jin s qing, doctor Sixth Affiliated Hospital, Sun Yat-sen University
  More Information

Additional Information:
PUMED  This link exits the ClinicalTrials.gov site

No publications provided by Sun Yat-sen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guangdong Science Committee
ClinicalTrials.gov Identifier: NCT01185535     History of Changes
Other Study ID Numbers: 20081110362101197410300047
Study First Received: July 26, 2010
Last Updated: August 19, 2010
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
topical anesthesia
tracheal intubation
difficult airway

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 25, 2014