Impact of Topical Pharyngeal Anesthetics on Discharge of the Patients When Used in Conjunction With Propofol Sedation in Routine EGD's

Local pharyngeal anesthetics when used in conjunction with IV sedatives such as
benzodiazepines may ease the endoscopy and the patient tolerance. They have been believed to
dull the gag reflex and smooth the process of intubation of the esophagus. However local
pharyngeal anesthetics beside increasing the total procedure time and delaying the discharge
of the patient can cause serious side effects including methemoglobinemia, aspiration and
anaphylactic reactions although these are rare. There have been studies supporting the use
of local pharyngeal anesthetics along with sedatives such as benzodiazepines and opiates
[1]. However there have been only a few studies on the use of local pharyngeal anesthetics
in conjunction with propofol which have not supported any added benefit of local pharyngeal
anesthetics [2, 3, 4]. Despite of these studies local pharyngeal anesthetics are still being
widely used in conjunction with propofol during EGD's. There are currently no set
recommendations or protocol for the use of local anesthetics such as lidocaine in
conjunction with propofol during EGD's. This study is yet another attempt to find out if the
local pharyngeal anesthetics have any role during EGD's when used in conjunction with
propofol.

This will be a randomized, double blind, placebo controlled trial. Patients scheduled to
have elective EGD's will be consented for their participation. CRNA's or anesthetists would
be present during all EGD's since propofol is only given by the anesthesia department
personnel. Five minutes prior to intravenous sedation the patients will be asked to gargle
with 7.5 ml of 2% lidocaine viscous solution or 7.5 ml of placebo and then swallow. Placebo
will be 3% methylcellulose which will be flavored and colored to match the characteristics
of 2 % lidocaine. The operating gastroenterologist after extubation will be asked to fill in
a questionnaire commenting on the ease of intubation and if they were able to make any
guesses whether lidocaine was used during the procedure or not. An independent observer will
be asked to fill in a questionnaire regarding their visual assessment about patient
discomfort during the procedure. the visual scale ranging from 1 cm to 10 cm and then the
observer; gastroenterologist would pick up a number with 0 being the worst satisfaction and
10 being the best satisfaction with the procedure. The questionnaire will also include the
number of times the patient gagged, number of intubation attempts by the gastroenterologist
and post procedure what did the gastroenterologist think if Lidocaine or placebo was used
during the procedure. The time after recovery from the sedatives till the patient is
discharged will be recorded as the primary end point. The total number of intubation
attempts, total amount of propofol used during the procedure and any above mentioned side
effects of lidocaine will be recorded as the secondary end points. The total procedure time
will also be recorded. Start time for the procedure will be when the first attempt for GI
scope insertion is made by the gastroenterologist after giving sedative. End time for the
procedure is when the GI scope is extubated. Throat pain/discomfort scores which are
routinely assessed and recorded prior to discharge will be assessed as a secondary endpoint.

Inclusion Criteria:

- Patients age 18 or older.

- Scheduled for an elective EGD.

Exclusion Criteria:

- Patients having EGD for urgent or emergent reasons.

- Patients having therapeutic EGD's.

- History of intolerance to either lidocaine or propofol.

- Pregnancy.

- Impaired swallowing reflex.

- Dementia

- Patients unable to consent on own for the procedure and/or research.

- Patient receiving any other sedative in addition to Propofol.