Effect of Lidocaine Sprayed on Hemodynamics During Endotracheal Intubation

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Seoul National University Hospital
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
  Purpose

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.


Condition Intervention
Neurosurgical Patients
Drug: group C
Drug: group L
Drug: group V
Drug: group LV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Lidocaine Sprayed on Direct Laryngoscopy and Trachea on Hemodynamics During Endotracheal Intubation

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group L
10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.
Drug: group L
10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.
Placebo Comparator: group C
0.9% normal saline was applied to trachea and laryngoscope blade in Group C.
Drug: group C
0.9% normal saline was applied to trachea and laryngoscope blade
Experimental: group V
0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.
Drug: group V
0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.
Experimental: group LV
10% Lidocaine was applied on laryngoscope blade and trachea.
Drug: group LV
10% Lidocaine was applied on laryngoscope blade and trachea.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01737437

Contacts
Contact: SUE YOUNG LEE, MD 82-10-9700-6509 tndude49@hanmail.net

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Hee-Pyoung PARK, MD PhD    82-2-2072-2466    hppark@snu.ac.kr   
Principal Investigator: Hee-Pyung Park, MD PhD         
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Hee-Pyoung Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01737437     History of Changes
Other Study ID Numbers: php1
Study First Received: November 20, 2012
Last Updated: November 26, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 29, 2014