Effect of Lidocaine Sprayed on Hemodynamics During Endotracheal Intubation
This study is currently recruiting participants.
Verified November 2012 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
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
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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
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 May 23, 2013