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Inhalation 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
New Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 21, 2013
Last Updated
April 23, 2013
Sponsor
New Taipei City Hospital
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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

Learn more about this trial

Inhalation of Lidocaine Before Intubation

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