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

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.

Study Overview

• Status: Completed
• Conditions: Topical Anesthesia
• Intervention / Treatment: Drug: Lidocaine; Drug: Propofol; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Cooperstown, New York, United States, 13326
      • Bassett Healthcare Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Viscous Lidocaine; Five minutes prior to intravenous sedation the patients will be asked to gargle with 7.5 ml of 2% lidocaine viscous solution and swallow.	Drug: Lidocaine; Prior to initiation of anesthesia viscous lidocaine or placebo will be administered.; Drug: Propofol; All patients will receive intravenous propofol as anesthesia for EGD
Placebo Comparator: Placebo; Five minutes prior to intravenous sedation the patients will be asked to gargle with 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.	Drug: Propofol; All patients will receive intravenous propofol as anesthesia for EGD; Drug: Placebo; Prior to initiation of anesthesia viscous lidocaine or placebo will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from study drug administration to discharge	The time from study drug administration to discharge from procedure area will be measured.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroenterologist satisfaction at time of intubation	Gastroenterologist performing the EGD will complete a 10 cm VAS scale indicating satisfaction with ease of intubation.	15 minutes
Propofol dose	total propofol dose administered during the procedure will be recorded.	30 minutes

Collaborators and Investigators

• Sponsor: Bassett Healthcare
• Investigators: Principal Investigator: david Ullman, MD, Bassett Healthcare

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 6, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Propofol; Lidocaine
• Other Study ID Numbers: 2017