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

Primary Purpose

Dysphagia, GERD, Abdominal Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Placebo
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring EGD, topical lidocaine, recovery time, intravenous sedation

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brooke Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Experimental

Arm Description

Patients will receive 10cc of 1/2 normal saline to gargle prior to EGD

Patients will receive 10cc of 2% topical lidocaine to gargle prior to EGD

Outcomes

Primary Outcome Measures

Amount of sedation used
We will record the amount of sedation used during the procedure

Secondary Outcome Measures

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

Full Information

First Posted
January 26, 2015
Last Updated
December 2, 2015
Sponsor
Brooke Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02620501
Brief Title
Does Use of Topical Lidocaine in EGD Reduce Amount of IV Midazolam and Fentanyl Required and Shorten Recovery Time
Official Title
Does Topical Lidocaine Reduce The Amount of Intravenous Conscious Sedation Required To Complete Diagnostic Upper Endoscopy and Shorten Recovery Time? A Double Blinded, Randomized, Placebo Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, GERD, Abdominal Pain
Keywords
EGD, topical lidocaine, recovery time, intravenous sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive 10cc of 1/2 normal saline to gargle prior to EGD
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients will receive 10cc of 2% topical lidocaine to gargle prior to EGD
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
topical lidocaine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.45% Normal Saline
Primary Outcome Measure Information:
Title
Amount of sedation used
Description
We will record the amount of sedation used during the procedure
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Recovery time
Description
We will record the amount of time it takes to recover following the procedure
Time Frame
120 minutes
Title
Patient and physician satisfaction
Description
We will assess patient and physician satisfaction with the procedure through use of a questionaire
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam M Tritsch, MD
Phone
210-916-4367
Email
adam.m.tritsch.mil@mail.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam M Tritsch, MD
Organizational Affiliation
Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
Ft. Sam Houston
State/Province
Texas
ZIP/Postal Code
78219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam M Tritsch, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
10406247
Citation
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.
Results Reference
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Does Use of Topical Lidocaine in EGD Reduce Amount of IV Midazolam and Fentanyl Required and Shorten Recovery Time

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