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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02507440
Enrollment
100
Registered
2015-07-24
Start date
2015-09-30
Completion date
2016-11-30
Last updated
2017-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topical Anesthesia

Brief summary

To find out if the administration of the local pharyngeal anesthetic, lidocaine, in conjunction with Propofol during elective Esophagogastroduodenoscopy (EGD) is useful, safe and impacts the time of discharge of patient compared to placebo.

Detailed description

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.

Interventions

DRUGLidocaine

Prior to initiation of anesthesia viscous lidocaine or placebo will be administered.

DRUGPlacebo

Prior to initiation of anesthesia viscous lidocaine or placebo will be administered.

DRUGPropofol

All patients will receive intravenous propofol as anesthesia for EGD

Sponsors

Bassett Healthcare
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time from study drug administration to discharge3 hoursThe time from study drug administration to discharge from procedure area will be measured.

Secondary

MeasureTime frameDescription
Gastroenterologist satisfaction at time of intubation15 minutesGastroenterologist performing the EGD will complete a 10 cm VAS scale indicating satisfaction with ease of intubation.
Propofol dose30 minutestotal propofol dose administered during the procedure will be recorded.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026