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NCT01838993 Clinical Trial

Inhalation of Lidocaine Before Intubation

Sore Throat Clinical Trial

Official title:
The Effect of Ultrasonic Nebulizer Delivered Lidocaine on Circulatory Responses During Tracheal Intubation and Postoperative Sore Throat

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01838993
Other study ID # CS 2013011
Secondary ID
Status Recruiting
Phase N/A
First received April 21, 2013
Last updated April 23, 2013
Start date January 2013

Study information
Verified date April 2013
Source New Taipei City Hospital
Contact Chen Yen Po, MD
Email drbrianchan@yahoo.com.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately before induction.

Description:

Sudden increases in blood pressure and heart rate after tracheal intubation and post-operative sore throat are two common undesirable side effects of general anesthesia and might lead to patients' morbidity or dissatisfaction. We investigated the possibility to attenuate both side effects with one single method, i.e. ultrasound-driven lidocaine inhalation immediately before induction.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists (ASA) physical status I or II. Patients scheduled for elective surgery under general anesthesia with orotracheal intubation

Exclusion Criteria:

- patient's refusal to join, major surgery or expected operation duration longer than 3 hours, patients with a anticipated difficult airway, requiring a nasogastric tube in peri-operative stage, having recent upper respiratory tract infection (within 1 week) or pre-existing sore throat.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine inhalation
Lidocaine inhalation before intubation
• Placebo

Locations
Country Name City State
Taiwan New Taipei City Hospital New Taipei City

Sponsors (1)
Lead Sponsor Collaborator
New Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure Non invasive blood pressure every min for 3 min 3 min No
Secondary Post operative sore throat Questionnaire for Post operative sore throat 3 days No
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