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

Conditions:Gastroesophageal Reflux Disease , Gastrointestinal, Pain
Therapuetic Areas:Gastroenterology, Musculoskeletal
Age Range:18 - 89
Start Date:July 2015
End Date:May 2016
Contact:Adam M Tritsch, MD

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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.

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..

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

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
We found this trial at
Ft. Sam Houston, Texas 78234
Ft. Sam Houston, TX
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