Effect of Lidocaine Sprayed on Hemodynamics During Endotracheal Intubation

NCT01737437 | Unknown

• 1 other identifier: php1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurosurgical Patients

Outcome Measures

Primary Outcomes (1)

• mean blood pressure, heart rate

  baseline, at laryngoscope insertion, 60s after laryngoscope insertion, during intubation, one, two, three min after endotracheal intubation

Study Arms (4)

group L

EXPERIMENTAL

10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.

Drug: group L

group C

PLACEBO COMPARATOR

0.9% normal saline was applied to trachea and laryngoscope blade in Group C.

Drug: group C

group V

EXPERIMENTAL

0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.

Drug: group V

group LV

EXPERIMENTAL

10% Lidocaine was applied on laryngoscope blade and trachea.

Drug: group LV

Interventions

group C DRUG

0.9% normal saline was applied to trachea and laryngoscope blade

group C

group L DRUG

10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.

group L

group V DRUG

0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.

group V

group LV DRUG

10% Lidocaine was applied on laryngoscope blade and trachea.

group LV

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged 20-60 years,
• ASA groups I or II

You may not qualify if:

• ASA III or IV,
• hypertension,
• anticipated difficult airway, and
• severe coronary and cerebrovascular diseases

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

RECRUITING

Central Study Contacts

SUE YOUNG LEE, MD

CONTACT

82-10-9700-6509; tndude49@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 29, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

KR (1)