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

Study Overview
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Brief Summary
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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
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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..

Official Title
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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.

Conditions
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Dysphagia, GERD, Abdominal Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients will receive 10cc of 1/2 normal saline to gargle prior to EGD | Drug: Placebo<br>* 0.45% Normal Saline<br>|
| Experimental: Experimental<br>Patients will receive 10cc of 2% topical lidocaine to gargle prior to EGD | Drug: Lidocaine<br>* topical lidocaine<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGD, topical lidocaine, recovery time, intravenous sedation