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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Pain; Dysphagia; GERD
• Intervention / Treatment: Drug: Placebo; Drug: Lidocaine

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 Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Ft. Sam Houston, Texas, United States, 78219
      • Recruiting
      • Brooke Army Medical Center
      • Contact: Adam M Tritsch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Investigators: Principal Investigator: Adam M Tritsch, MD, Brooke Army Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: EGD; topical lidocaine; recovery time; intravenous sedation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: BrookeAMC