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.
1 other identifier
interventional
106
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedDecember 3, 2015
December 1, 2015
7 months
January 26, 2015
December 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of sedation used
We will record the amount of sedation used during the procedure
60 minutes
Secondary Outcomes (2)
Recovery time
120 minutes
Patient and physician satisfaction
24 hours
Study Arms (2)
Placebo
PLACEBO COMPARATORPatients will receive 10cc of 1/2 normal saline to gargle prior to EGD
Experimental
EXPERIMENTALPatients will receive 10cc of 2% topical lidocaine to gargle prior to EGD
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brooke Army Medical Center
Fort Sam Houston, Texas, 78219, United States
Related 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. doi: 10.1111/j.1572-0241.1999.01217.x.
PMID: 10406247BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam M Tritsch, MD
Brooke Army Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gastroenterology Fellow
Study Record Dates
First Submitted
January 26, 2015
First Posted
December 3, 2015
Study Start
July 1, 2015
Primary Completion
February 1, 2016
Study Completion
May 1, 2016
Last Updated
December 3, 2015
Record last verified: 2015-12