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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02620501
Other study ID # BrookeAMC
Secondary ID
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


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
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