Clinical trial NCT02620501: Does Use of Topical Lidocaine in EGD Reduce Amount of IV Midazolam and Fentanyl Required and Shorten Recovery Time
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
GERD
Abdominal Pain
Keywords: EGD
topical lidocaine
recovery time
intravenous sedation
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2015-12-03
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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..

Eligibility criteria: 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

Primary outcomes:
measure: Amount of sedation used
timeFrame: 60 minutes
Secondary outcomes:
measure: Recovery time
timeFrame: 120 minutes
measure: Patient and physician satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ft. Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Adam M Tritsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.