Back to resultsInhalation of Lidocaine Before Intubation
Primary Purpose
Sore Throat
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lidocaine inhalation
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Sore Throat focused on measuring anesthetics,, local,, lidocaine;, nebulizers and vaporizers;, complications,, intubation,, intratracheal.
Eligibility Criteria
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.
Sites / Locations
- New Taipei City HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lidocaine
Control
Arm Description
Inhalation of lidocaine before intubation
Normal saline inhalation before intubation
Outcomes
Primary Outcome Measures
Blood pressure
Non invasive blood pressure every min for 3 min
Secondary Outcome Measures
Post operative sore throat
Questionnaire for Post operative sore throat
Full Information
NCT ID
NCT01838993
First Posted
April 21, 2013
Last Updated
April 23, 2013
Sponsor
New Taipei City Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01838993
Brief Title
Inhalation of Lidocaine Before Intubation
Official Title
The Effect of Ultrasonic Nebulizer Delivered Lidocaine on Circulatory Responses During Tracheal Intubation and Postoperative Sore Throat
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New Taipei City Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately before induction.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat
Keywords
anesthetics,, local,, lidocaine;, nebulizers and vaporizers;, complications,, intubation,, intratracheal.
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Inhalation of lidocaine before intubation
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Normal saline inhalation before intubation
Intervention Type
Drug
Intervention Name(s)
Lidocaine inhalation
Intervention Description
Lidocaine inhalation before intubation
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Blood pressure
Description
Non invasive blood pressure every min for 3 min
Time Frame
3 min
Secondary Outcome Measure Information:
Title
Post operative sore throat
Description
Questionnaire for Post operative sore throat
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Yen Po, MD
Email
drbrianchan@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Yen Po, MD
Organizational Affiliation
New Taipei City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Taipei City Hospital
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Chi-Hsuan, MD
Email
ad2354@ntpc.gov.tw
12. IPD Sharing Statement
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Inhalation of Lidocaine Before Intubation
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