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

Not Applicable

• Conditions: Dysphagia; GERD; Abdominal Pain
• Interventions: Drug: Placebo; Drug: Lidocaine

• Registration Number: NCT02620501
• Lead Sponsor: Brooke Army Medical Center

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..

Study Timeline

• Study First Submitted: 2015-01-26
• Study Start: 2015-07
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-02
• Last Update Submitted: 2015-12-02
• Study First Posted: 2015-12-03
• Last Update Posted: 2015-12-03
• Primary Completion: 2016-02
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will receive 10cc of 1/2 normal saline to gargle prior to EGD
Experimental	Lidocaine	Patients will receive 10cc of 2% topical lidocaine to gargle prior to EGD

Primary Outcome Measures

Name	Time	Method
Amount of sedation used	60 minutes	We will record the amount of sedation used during the procedure

Secondary Outcome Measures

Name	Time	Method
Recovery time	120 minutes	We will record the amount of time it takes to recover following the procedure
Patient and physician satisfaction	24 hours	We will assess patient and physician satisfaction with the procedure through use of a questionaire

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Ft. Sam Houston, Texas, United States