Topical Pharyngeal Anesthesia in Sedated Esophagogastroduodenoscopy

The Application of Topical Pharyngeal Anesthesia in the Esophagogastroduodenoscopy Under Sedation

At recent, the number of patients who underwent sedated esophagogastroduodenoscopy has been on the increase. For such patients, whether topical pharyngeal anesthesia is needed remains to be controversial. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline for non-anesthesiologist administration of propofol for GI endoscopy have not made any recommendation, because the role of pharyngeal anesthesia during propofol sedation for upper digestive endoscopy has not been assessed. Our study aimed at investigating whether topical lidocaine pharyngeal anesthesia could benefit patients who underwent esophagogastroduodenoscopy under propofol sedation.

Study Overview

• Status: Unknown
• Conditions: Esophagogastroduodenoscopy
• Intervention / Treatment: Procedure: Topical lidocaine pharyngeal anesthesia

Detailed Description

Propofol sedation has been widely applied in endoscopic examinations. For such patients, whether lidocaine topical pharyngeal anesthesia should be administrated is still in doubt. Considering the fact that lidocaine anesthesia may cause airway narrowing and anaphylaxis, it is important to clarify the role of lidocaine topical pharyngeal anesthesia in esophagogastroduodenoscopy under propofol sedation. Our study could test whether lidocaine topical pharyngeal anesthesia should be performed in sedated esophagogastroduodenoscopy in a randomized controlled trial.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100071
    • Recruiting
    • Affiliated Hospital to Academy of Military Medical Sciences
    • Contact: Yan Liu, M.D., Ph.D.; Phone Number: +86-010-66947473; Email: 13911798288@163.com

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 ≥18 Years
• Patients who have indications for esophagogastroduodenoscopy
• American Society of Anesthesiology risk class 1, 2 or 3

Exclusion Criteria:

• Patients <18 years
• Patients with thrombocytopenia (platelet count < 50,000/microL) or elevated International Normalized Ratio (INR > 1.5)
• Hemodynamic instability
• Pregnancy and lactation
• Patients who are unable or unwilling to give an informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Topical lidocaine pharyngeal anesthesia was performed.	Procedure: Topical lidocaine pharyngeal anesthesia; Topical pharyngeal anesthesia by lidocaine was administrated 4-5 min before propofol sedation in patients who underwent esophagogastroduodenoscopy.
No Intervention: Control group; No topical lidocaine pharyngeal anesthesia was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate throat pain score	Immediate throat discomfort will be recorded, and pain score (0 no pain - 10 most painful) will be given by the patients.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Throat discomfort 1 day after the procedure	All the patients will be followed up by telephone 1 day after the endoscopic examination. Throat Discomfort will be recorded.	1 day
Adverse events	All the adverse events during the sedated endoscopic examination will be recorded.	1 day
Satisfaction score	Patients will give a satisfaction score of 0 (unsatisfied) -10 (very satisfied) based on their own experience.	1 day

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Principal Investigator: Yang Liu, M.D., Ph.D., Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences

Publications and helpful links

General Publications

• Heuss LT, Hanhart A, Dell-Kuster S, Zdrnja K, Ortmann M, Beglinger C, Bucher HC, Degen L. Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial. Gastrointest Endosc. 2011 Dec;74(6):1207-14. doi: 10.1016/j.gie.2011.07.072. Epub 2011 Oct 13.
• Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.
• Sun X, Xu Y, Zhang X, Li A, Zhang H, Yang T, Liu Y. Topical pharyngeal anesthesia provides no additional benefit to propofol sedation for esophagogastroduodenoscopy: a randomized controlled double-blinded clinical trial. Sci Rep. 2018 Apr 27;8(1):6682. doi: 10.1038/s41598-018-25164-7.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: February 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; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 307-TA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No