Does Use of Topical Lidocaine in EGD Reduce Amount of IV Midazolam and Fentanyl Required and Shorten Recovery Time
NCT ID: NCT02620501
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
106 participants
INTERVENTIONAL
2015-07-31
2016-05-31
Brief Summary
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Detailed Description
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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..
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Patients will receive 10cc of 1/2 normal saline to gargle prior to EGD
Placebo
0.45% Normal Saline
Experimental
Patients will receive 10cc of 2% topical lidocaine to gargle prior to EGD
Lidocaine
topical lidocaine
Interventions
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Lidocaine
topical lidocaine
Placebo
0.45% Normal Saline
Eligibility Criteria
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Inclusion Criteria
* Between the age of 18 and 89
* Not requiring anesthesia support or use of medications other than fentanyl and midazolam
Exclusion Criteria
* 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
18 Years
89 Years
ALL
No
Sponsors
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Brooke Army Medical Center
FED
Responsible Party
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Adam Tritsch
Gastroenterology Fellow
Principal Investigators
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Adam M Tritsch, MD
Role: PRINCIPAL_INVESTIGATOR
Brooke Army Medical Center
Locations
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Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Adam M Tritsch, MD
Role: primary
References
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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.
Other Identifiers
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BrookeAMC
Identifier Type: -
Identifier Source: org_study_id