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

Not Applicable

Recruiting

• Conditions: Tachycardia; Blood Pressure
• Interventions: Drug: Lidocaine

• Registration Number: NCT06497296
• Lead Sponsor: National Cheng-Kung University Hospital

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.

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 Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study First Posted: 2024-07-11
• Last Update Posted: 2024-07-11
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-minute group	Lidocaine	6 puff of lidocaine was delivered 1 minute before the initiation of EGD insertion
3-minute group	Lidocaine	6 puff of lidocaine was delivered 3 minutes before the initiation of EGD insertion

Primary Outcome Measures

Name	Time	Method
Blood pressure change	1 day	The increase level of systolic blood pressure between baseline and during the pharynx insertion of EGD
Heart rate change	1 day	The increase level of heart rate between baseline and during the pharynx insertion of EGD

Secondary Outcome Measures

Name	Time	Method
EGD comfort quality questionnaire score	1 day	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.

Trial Locations

Locations (1)

Hsueh-Chien Chiang; 🇨🇳 Tainan, Other (Non U.s.), Taiwan