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NCT Number: NCT06497296

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.

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Key information

Conditions

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

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hsueh-Chien Chiang

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

Location status: Recruiting

Location contact

Hsueh-Chien Chiang

CONTACT

[email protected]

2353535

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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

Primary outcomes

  1. Heart rate change

    Time frame: 1 day

    The increase level of heart rate between baseline and during the pharynx insertion of EGD

  2. Blood pressure change

    Time frame: 1 day

    The increase level of systolic blood pressure between baseline and during the pharynx insertion of EGD

Secondary outcomes

  1. EGD comfort quality questionnaire score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hsueh-Chien Chiang, M.D.

CONTACT

[email protected]

062353535

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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