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

Brooke Army Medical Center

Status: Unknown

Conditions: Dysphagia; GERD; Abdominal Pain

Treatments: Drug: Lidocaine; Drug: Placebo

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02620501

BrookeAMC

Details and patient eligibility

About

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.

Full 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..

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Experimental

Experimental group

Description:

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

Treatment:

Drug: Lidocaine