Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Lidocaine Sprayed on Hemodynamics During Endotracheal Intubation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hee-Pyoung Park, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01737437
First received: November 20, 2012
Last updated: November 26, 2012
Last verified: November 2012

November 20, 2012
November 26, 2012
October 2012
January 2013   (final data collection date for primary outcome measure)
mean blood pressure, heart rate [ Time Frame: baseline, at laryngoscope insertion, 60s after laryngoscope insertion, during intubation, one, two, three min after endotracheal intubation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01737437 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Lidocaine Sprayed on Hemodynamics During Endotracheal Intubation
Effect of Lidocaine Sprayed on Direct Laryngoscopy and Trachea on Hemodynamics During Endotracheal Intubation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Neurosurgical Patients
  • Drug: group C
    0.9% normal saline was applied to trachea and laryngoscope blade
  • Drug: group L
    10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.
  • Drug: group V
    0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.
  • Drug: group LV
    10% Lidocaine was applied on laryngoscope blade and trachea.
  • Experimental: group L
    10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.
    Intervention: Drug: group L
  • Placebo Comparator: group C
    0.9% normal saline was applied to trachea and laryngoscope blade in Group C.
    Intervention: Drug: group C
  • Experimental: group V
    0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.
    Intervention: Drug: group V
  • Experimental: group LV
    10% Lidocaine was applied on laryngoscope blade and trachea.
    Intervention: Drug: group LV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
Yes
Contact: SUE YOUNG LEE, MD 82-10-9700-6509 tndude49@hanmail.net
Korea, Republic of
 
NCT01737437
php1
No
Hee-Pyoung Park, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP