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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Blood Pressure Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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1-minute group

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

Group Type PLACEBO_COMPARATOR

Lidocaine

Intervention Type DRUG

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

3-minute group

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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

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

Interventions

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Lidocaine

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

Intervention Type DRUG

Eligibility Criteria

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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