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

ConditionsBlood PressureTachycardia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-90
SponsorNational Cheng-Kung University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

GI bleeding

endoscopic submucosal dissection due to prolonged scheduled procedure time

patients from emergency department or ward

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine

    Drug

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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: 1-minute groupPlacebo comparator 1 intervention
Group B: 3-minute groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Heart rate change

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

Time frame
1 day
2

Blood pressure change

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

Time frame
1 day

Secondary outcomes

1

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.

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cheng-Kung University Hospital

Lead sponsor

Source ClinicalTrials.gov
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