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

NCT06497296 | Recruiting

• 1 other identifier: B-ER-111-218
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure; Tachycardia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• EGD comfort quality questionnaire score

  1 day

Study Arms (2)

1-minute group

PLACEBO COMPARATOR

6 puff of lidocaine was delivered 1 minute before the initiation of EGD insertion

Drug: Lidocaine

3-minute group

ACTIVE COMPARATOR

6 puff of lidocaine was delivered 3 minutes before the initiation of EGD insertion

Drug: Lidocaine

Interventions

Lidocaine DRUG

Lidocaine spray in both group with same puff number, but the timing before EGD insertion is different

1-minute group; 3-minute group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Hsueh-Chien Chiang

Tainan, Other (Non U.s.), 704, Taiwan

RECRUITING

Related Publications (8)

• 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.

  PMID: 25480102 RESULT

• 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.

  PMID: 22985638 RESULT

• Lazzaroni M, Bianchi Porro G. Preparation, premedication, and surveillance. Endoscopy. 2005 Feb;37(2):101-9. doi: 10.1055/s-2004-826149.

  PMID: 15692924 RESULT

• 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.

  PMID: 8514070 RESULT

• 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.

  PMID: 16650534 RESULT

• 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.

  PMID: 24682602 RESULT

• 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.

  PMID: 34644419 RESULT

• Chiang HC, Chiang CM, Chang WL, Lin MY. Clinical Trial: The Optimal Timing of the Endoscope Insertion After Oral Lidocaine Spray. A Randomized Controlled Trial. J Gastroenterol Hepatol. 2025 Jun;40(6):1428-1434. doi: 10.1111/jgh.16958. Epub 2025 Apr 1.

  PMID: 40166898 DERIVED

MeSH Terms

Conditions

Tachycardia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Hsueh-Chien Chiang, M.D.

CONTACT

062353535; scion456scion@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sealed and ordered envelope will be opened by assistant and the allocation was written on it. After then, lidocaine spray will be administered. The operator will be informed to prepare 30 seconds before the EGD initiation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Both group accepted 6 puff of lidocaine spray. EGD will be inserted one minute after the lidocaine spray in 1-minute group and 3 minutes waiting in 3-minute group

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 11, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TW (1)