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.
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brooke Army Medical Center | Ft. Sam Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center |
United States,
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
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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