The Optimal Timing of the Initiation of Esophagogastroduodenoscopy After Oral Lidocaine Spray

Esophagogastroduodenoscopy (EGD) is the main examination in the upper gastrointestinal field. Aspiration pneumonia may happen if choking occurs during the EGD insertion, and the exam quality and efficacy may be affected if gag reflex occurs. The endoscopist may terminate the exam to avoid complications if the patient could not obey the orders. To reach the high quality of EGD examination and to avoid possible complications, the patient's comfort and compliance during the EGD examination are important. Sedation using propofol can improve the patient's comfort and compliance. However, in patients unsuitable for systemic anesthesia, local lidocaine spray at pharynx is performed instead. Until now, there is no standardization of the waiting time between lidocaine spray and the initiation of EGD. This study aimed to investigate the optimal timing of the initiation of esophagogastroduodenoscopy after lidocaine spray.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure; Tachycardia
• Intervention / Treatment: Drug: Lidocaine

Detailed Description

This study compares the 1-minute waiting time and 3-minute waiting time between the lidocaine spray and the EGD initiation. During the topical anesthesia stage, investigators give local spray with 6 puff on pharynx at the 0 minute in both groups. After the waiting time, EGD is inserted.

The baseline heart rate and blood pressure were recorded before EGD and during the EGD passing through pharynx respectively. After the whole procedure, enrolled patients will fill in the EGD quality questionnaire.

Through this study, investigators can figure out whether 1 minute or 3 minutes may be the optimal waiting time after lidocaine spray.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsueh-Chien Chiang, M.D.; Phone Number: 062353535; Email: scion456scion@gmail.com

Study Locations

• Taiwan
  • Other (Non U.s.)
    • Tainan, Other (Non U.s.), Taiwan, 704
      • Recruiting
      • Hsueh-Chien Chiang
      • Contact: Hsueh-Chien Chiang; Phone Number: 2353535; Email: scion456scion@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible participants included patients aged ≥ 20 years who scheduled EGD from OPD for dyspepsia, peptic ulcer disease, GERD, subepithelial lesion evaluation, and diarrhea

Exclusion Criteria:

• GI bleeding
• endoscopic submucosal dissection due to prolonged scheduled procedure time
• patients from emergency department or ward

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
Placebo Comparator: 1-minute group; 6 puff of lidocaine was delivered 1 minute before the initiation of EGD insertion	Drug: Lidocaine; Lidocaine spray in both group with same puff number, but the timing before EGD insertion is different
Active Comparator: 3-minute group; 6 puff of lidocaine was delivered 3 minutes before the initiation of EGD insertion	Drug: Lidocaine; Lidocaine spray in both group with same puff number, but the timing before EGD insertion is different

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate change	The increase level of heart rate between baseline and during the pharynx insertion of EGD	1 day
Blood pressure change	The increase level of systolic blood pressure between baseline and during the pharynx insertion of EGD	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EGD comfort quality questionnaire score	comfort quality questionnaire will be written by an assistant and the patient after the EGD procedure. The score includes pain feeling (1-5 points), nausea sensation (1-5 points), abdominal fullness (1-5 points). A higher score indicates more discomfort.	1 day

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Publications and helpful links

General Publications

• Evans LT, Saberi S, Kim HM, Elta GH, Schoenfeld P. Pharyngeal anesthesia during sedated EGDs: is "the spray" beneficial? A meta-analysis and systematic review. Gastrointest Endosc. 2006 May;63(6):761-6. doi: 10.1016/j.gie.2005.11.059.
• Rizk MK, Sawhney MS, Cohen J, Pike IM, Adler DG, Dominitz JA, Lieb JG 2nd, Lieberman DA, Park WG, Shaheen NJ, Wani S. Quality indicators common to all GI endoscopic procedures. Gastrointest Endosc. 2015 Jan;81(1):3-16. doi: 10.1016/j.gie.2014.07.055. Epub 2014 Dec 2. No abstract available.
• ASGE Standards of Practice Committee; Ben-Menachem T, Decker GA, Early DS, Evans J, Fanelli RD, Fisher DA, Fisher L, Fukami N, Hwang JH, Ikenberry SO, Jain R, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, Sharaf RN, Dominitz JA, Cash BD. Adverse events of upper GI endoscopy. Gastrointest Endosc. 2012 Oct;76(4):707-18. doi: 10.1016/j.gie.2012.03.252. No abstract available.
• Lazzaroni M, Bianchi Porro G. Preparation, premedication, and surveillance. Endoscopy. 2005 Feb;37(2):101-9. doi: 10.1055/s-2004-826149.
• Leitch DG, Wicks J, el Beshir OA, Ali SA, Chaudhury BK. Topical anesthesia with 50 mg of lidocaine spray facilitates upper gastrointestinal endoscopy. Gastrointest Endosc. 1993 May-Jun;39(3):384-7. doi: 10.1016/s0016-5107(93)70110-8.
• Hwang SH, Park CS, Kim BG, Cho JH, Kang JM. Topical anesthetic preparations for rigid and flexible endoscopy: a meta-analysis. Eur Arch Otorhinolaryngol. 2015 Feb;272(2):263-70. doi: 10.1007/s00405-014-3012-8. Epub 2014 Mar 29.
• Martin-Marcos I, Fernandez-Morte N, Balsategui-Martin M, Ortiz-Cantero A, Bermudez-Ampudia C, Lopez-Picado A, Perez-Vaquero P, Salvador-Perez M, Cristobal-Dominguez E. Evaluation of pharyngeal lidocaine anesthesia for esophagogastroduodenoscopy: Double-blind randomized control trial. Dig Endosc. 2022 May;34(4):808-815. doi: 10.1111/den.14168. Epub 2021 Nov 17.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; 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: B-ER-111-218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No