Does Use of Topical Lidocaine in EGD Reduce Amount of IV... | NCT02620501

Studies
Does Use of Topical Lidocaine in EGD Reduce Amount of IV Midazolam and Fentanyl Required and Shorten Recovery Time

NCT02620501

Sponsor

Brooke Army Medical Center

Status

Unknown status

Last Update Posted

Dec 3, 2015Estimated

Enrollment

106Estimated

Phase

Not Applicable

Conditions

Dysphagia
GERD
Abdominal Pain

Interventions

Lidocaine
Placebo

Countries

United States

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

Dec 2015

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

Jul 2015

Primary Completion Date

Feb 2016Estimated

Completion Date

May 2016Estimated

First Submitted Date

Jan 26, 2015

First Submission Date that Met QC Criteria

Dec 2, 2015

First Posted Date

Dec 3, 2015Estimated

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

Dec 2, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adam Tritsch, Gastroenterology Fellow, Brooke Army Medical CenterPrincipal Investigator

Lead Sponsor

Brooke Army Medical CenterFED

Collaborators

Not provided

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

Patients will be randomized to a placebo or study group who will receive topical lidocaine prior to EGD. Amount of medication used, recovery time, patient/endoscopist satisfaction will then be assessed.

Detailed Description

The study will be a double blinded randomized placebo controlled trial

Patients between 18 and 89 years old who are scheduled for EGD may be eligible to enroll in the study. Potential subjects will be sought through referral by their treating attending and fellow gastroenterologist, who will be apprised of the inclusion and exclusion criteria. Patients possibly meeting inclusive and exclusive criteria will be approached and discussed the study further with the investigators. Those expressing a desire to participate in the study will be given written informed consent prior to participation. The investigators will enroll patients into the study with a goal of at least 53 patients in each group which is the number of patients our statistician recommended to appropriately power our study.

Patients who consent to enroll in the study will be randomized into 2 groups. Group 1: Swish and swallow 10ml of 2% lidocaine solution Group 2: Swish and swallow 10ml of 0.45% sodium chloride solution

The patients will then undergo endoscopy for the indication identified in their clinic appointment. Following the procedure, patients will be taken to the recovery area and recovered per clinic protocol. The endoscopist will complete a satisfaction questionnaire. The day following the procedure a nurse will call to check for post-operative complications per clinic protocol. The day following, an investigator will also call to perform a patient satisfaction survey..

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

106Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Patients will receive 10cc of 1/2 normal saline to gargle prior to EGD	Drug: Placebo
Experimental	Experimental	Patients will receive 10cc of 2% topical lidocaine to gargle prior to EGD	Drug: Lidocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine	Drug	topical lidocaine	Experimental
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of sedation used	We will record the amount of sedation used during the procedure	60 minutes

Secondary Outcomes

Measure	Description	Time Frame
Recovery time	We will record the amount of time it takes to recover following the procedure	120 minutes
Patient and physician satisfaction	We will assess patient and physician satisfaction with the procedure through use of a questionaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

EGD alone performed by staff gastroenterologist as an outpatient
Between the age of 18 and 89
Not requiring anesthesia support or use of medications other than fentanyl and midazolam

Exclusion Criteria:

Prior history of head and neck surgery
Known hypersensitivity to local anesthetics, the amide type or any components of the topical lidocaine
Patients having interventions other than polypectomy performed
Pregnant or breast feeding females
Patients with severe liver impairment
Known hypersensitivity to benzodiazepine or fentanyl

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Adam M Tritsch, MD	Contact	210-916-4367		adam.m.tritsch.mil@mail.mil

Overall Officials

Name	Affiliation	Role
Adam M Tritsch, MD	Brooke Army Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brooke Army Medical Center	Recruiting	Fort Sam Houston	Texas	78219	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10406247	Background	Davis DE, Jones MP, Kubik CM. Topical pharyngeal anesthesia does not improve upper gastrointestinal endoscopy in conscious sedated patients. Am J Gastroenterol. 1999 Jul;94(7):1853-6. doi: 10.1111/j.1572-0241.1999.01217.x.

ID	Term
D003680	Deglutition Disorders
D005764	Gastroesophageal Reflux
D015746	Abdominal Pain

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814