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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06497296
Enrollment
160
Registered
2024-07-11
Start date
2023-01-01
Completion date
2024-12-31
Last updated
2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Tachycardia

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.

Interventions

DRUGLidocaine

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

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Heart rate change1 dayThe increase level of heart rate between baseline and during the pharynx insertion of EGD
Blood pressure change1 dayThe increase level of systolic blood pressure between baseline and during the pharynx insertion of EGD

Secondary

MeasureTime frameDescription
EGD comfort quality questionnaire score1 daycomfort 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.

Countries

Taiwan

Contacts

Primary ContactHsueh-Chien Chiang, M.D.
scion456scion@gmail.com062353535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026