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

NCT02507440 | Completed Phase 4

• 1 other identifier: 2017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Topical Anesthesia

Outcome Measures

Primary Outcomes (1)

• Time from study drug administration to discharge

  The time from study drug administration to discharge from procedure area will be measured.

  3 hours

Secondary Outcomes (2)

• Gastroenterologist satisfaction at time of intubation

  15 minutes

• Propofol dose

  30 minutes

Study Arms (2)

Viscous Lidocaine

ACTIVE COMPARATOR

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; Drug: Propofol

Placebo

PLACEBO COMPARATOR

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; Drug: Propofol

Interventions

Lidocaine DRUG

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

Viscous Lidocaine

Placebo DRUG

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

Placebo

Propofol DRUG

All patients will receive intravenous propofol as anesthesia for EGD

Placebo; Viscous Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 or older.
• Scheduled for an elective EGD.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bassett Healthcare: lead

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

MeSH Terms

Interventions

Lidocaine; Propofol

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• david Ullman, MD

  Bassett Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician - Anesthesiology

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 24, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

US (1)