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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

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ClinicalTrials.gov Identifier: NCT02507440
Recruitment Status : Completed
First Posted : July 24, 2015
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
David A Ullman MD, Bassett Healthcare

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.

Condition or disease Intervention/treatment Phase
Topical Anesthesia Drug: Lidocaine Drug: Placebo Drug: Propofol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Topical Pharyngeal Anesthetics on Discharge of the Patients When Used in Conjunction With Propofol Sedation in Routine EGD's
Study Start Date : September 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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

Drug: Propofol
All patients will receive intravenous propofol as anesthesia for EGD




Primary Outcome Measures :
  1. Time from study drug administration to discharge [ Time Frame: 3 hours ]
    The time from study drug administration to discharge from procedure area will be measured.


Secondary Outcome Measures :
  1. Gastroenterologist satisfaction at time of intubation [ Time Frame: 15 minutes ]
    Gastroenterologist performing the EGD will complete a 10 cm VAS scale indicating satisfaction with ease of intubation.

  2. Propofol dose [ Time Frame: 30 minutes ]
    total propofol dose administered during the procedure will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507440


Locations
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United States, New York
Bassett Healthcare Network
Cooperstown, New York, United States, 13326
Sponsors and Collaborators
Bassett Healthcare
Investigators
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Principal Investigator: david Ullman, MD Bassett Healthcare
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Responsible Party: David A Ullman MD, Attending Physician - Anesthesiology, Bassett Healthcare
ClinicalTrials.gov Identifier: NCT02507440    
Other Study ID Numbers: 2017
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Lidocaine
Propofol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General