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

Dysphagia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02620501
• Other study ID #: BrookeAMC
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2015
• Last updated: December 2, 2015
• Start date: July 2015
• Est. completion date: May 2016

Study information

• Verified date: December 2015
• Source: Brooke Army Medical Center
• Contact: Adam M Tritsch, MD
• Phone: 210-916-4367
• Email: adam.m.tritsch.mil[@]mail.mil
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Dysphagia
• GERD

Intervention

Drug:
• Lidocaine
topical lidocaine
• Placebo
0.45% Normal Saline

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Ft. Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of sedation used	We will record the amount of sedation used during the procedure	60 minutes	No
Secondary	Recovery time	We will record the amount of time it takes to recover following the procedure	120 minutes	No
Secondary	Patient and physician satisfaction	We will assess patient and physician satisfaction with the procedure through use of a questionaire	24 hours	No