Effect on Postoperative Sore Throat of Lidocaine Jelly Ap... | NCT02952157

Studies
Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff

NCT02952157

Sponsor

Keimyung University Dongsan Medical Center

Status

Unknown status

Last Update Posted

Nov 2, 2016Estimated

Enrollment

210Estimated

Phase

Phase 4

Conditions

Sore Throat

Interventions

Lidocaine jelly application
Normal saline application

Countries

Not provided

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Nov 2016Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Oct 20, 2016

First Submission Date that Met QC Criteria

Oct 30, 2016

First Posted Date

Nov 2, 2016Estimated

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

Oct 30, 2016

Last Update Posted Date

Nov 2, 2016Estimated

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

Postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. The investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Sham Comparator	Normal saline will be applied to the endotracheal tube.	Drug: Normal saline application
Lidocaine	Active Comparator	Lidocaine jelly will be applied to the endotracheal tube.	Drug: Lidocaine jelly application

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine jelly application	Drug		Lidocaine
Normal saline application

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with sore throat		At 24 hr

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with sore throat		At 1, 6, and 12 hr
Number of participants with hoarseness		At 1, 6, 12 and 24 hr
Number of participants with throat numbness

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-III
Patients scheduled for general anesthesia with endotracheal intubation
Patients scheduled for surgery which duration is expected to less than 3 hr

Exclusion Criteria:

Difficult airway
Rapid sequence induction
Recent sore throat
Recent upper respiratory infection
Asthma
Chronic obstructive pulmonary disease
Chronic cough
Pregnancy
Allergy to lidocaine
Friable teeth
History of head and neck surgery
Multiple intubation attempts
Regional anesthetic agents
Gastric tube
Dexamethasone

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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