Inhalation of Lidocaine Before Intubation | NCT01838993

Studies
Inhalation of Lidocaine Before Intubation

NCT01838993

Sponsor

New Taipei City Hospital

Status

Unknown status

Last Update Posted

Apr 24, 2013Estimated

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Sore Throat

Interventions

Lidocaine inhalation
Placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

May 2013Estimated

Completion Date

Not provided

First Submitted Date

Apr 21, 2013

First Submission Date that Met QC Criteria

Apr 23, 2013

First Posted Date

Apr 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2013

Last Update Posted Date

Apr 24, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lidocaine	Active Comparator	Inhalation of lidocaine before intubation	Drug: Lidocaine inhalation
Control	Placebo Comparator	Normal saline inhalation before intubation	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine inhalation	Drug	Lidocaine inhalation before intubation	Lidocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure	Non invasive blood pressure every min for 3 min	3 min

Secondary Outcomes

Measure	Description	Time Frame
Post operative sore throat	Questionnaire for Post operative sore throat	3 days

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chen Yen Po, MD	Contact			drbrianchan@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Chen Yen Po, MD	New Taipei City Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Taipei City Hospital	Recruiting	New Taipei City			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D010612	Pharyngitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided