Effect of Lidocaine Sprayed on Hemodynamics During Endotracheal Intubation

Neurosurgical Patients Clinical Trial

Official title:

Effect of Lidocaine Sprayed on Direct Laryngoscopy and Trachea on Hemodynamics During Endotracheal Intubation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01737437
• Other study ID #: php1
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2012
• Last updated: November 26, 2012
• Start date: October 2012
• Est. completion date: January 2013

Study information

• Verified date: November 2012
• Source: Seoul National University Hospital
• Contact: SUE YOUNG LEE, MD
• Phone: 82-10-9700-6509
• Email: tndude49[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A previous study demonstrated topical lidocaine spray on the larynx and the trachea is effective in reducing hemodynamic response to laryngoscopy and endotracheal intubation. In clinical practice, blind oropharyngeal application of lidocaine without aiding direct laryngoscopy can not assured that sprayed lidocaine effectively reaches the larynx and trachea. Therefore, direct laryngoscopy should be necessary to reach topical lidocaine to correct sites. Unfortunately, direct laryngoscopy itself can affect hemodynamics during spraying lidocaine. In this study, we will investigate an effect of lidocaine sprayed on direct laryngoscopy and the tracheal mucosa on hemodynamic change throughout intubation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• aged 20-60 years,

• ASA groups I or II

Exclusion Criteria:

• ASA III or IV,

• hypertension,

• anticipated difficult airway, and

• severe coronary and cerebrovascular diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neurosurgical Patients

Intervention

Drug:
• group C
0.9% normal saline was applied to trachea and laryngoscope blade
• group L
10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.
• group V
0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.
• group LV
10% Lidocaine was applied on laryngoscope blade and trachea.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean blood pressure, heart rate		baseline, at laryngoscope insertion, 60s after laryngoscope insertion, during intubation, one, two, three min after endotracheal intubation	No