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CompletedNCT02543411Updated Dec 15, 2015

Use of Lidocaine in Endoscopic Submucosal Dissection

An interventional study of Lidocaine 1% and Normal saline in Gastric Neoplasm, sponsored by Severance Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-12-15.

Sponsored by Severance Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

The primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection.

The secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.

02

Conditions studied

  • Gastric Neoplasm
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 66 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Severance Hospital is the lead sponsor of 50 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Endoscopic submucosal dissection for the treatments of early gastric neoplasm

Exclusion criteria

Exclusion Criteria:

  1. Allergy to lidocaine
  2. Chronic pain
  3. Chronic abuse of opioid or NSAID
  4. Atrioventricular conductance block
  5. Liver dysfunction
  6. Renal dysfunction
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Lidocaine group

    Administration of lidocaine 1%

    Drug: Lidocaine 1%

  • Placebo comparator
    Control group

    Administration of normal saline

    Drug: Normal saline

Interventions

  • DrugLidocaine 1%

    Intravenous administration as bolus of lidocaine 1.5 mg/kg before sedation and infusion of lidocaine 2 mg/kg/hr during sedation. Sedation with fentanyl and propofol

  • DrugNormal saline

    Intravenous administration as bolus of normal saline 0.15 mL/kg before sedation and infusion of normal saline 0.2 mL/kg/hr during sedation. Sedation with fentanyl and propofol

06

What researchers measure

Primary outcomes

  1. Fentanyl consumption during sedation

    Time frame: During sedation, an expected average of 40 minutes

Secondary outcomes

  1. Pain intensity measured by numerical rating scale

    0 = no pain at all and 10 = worst pain imaginable (11-point numerical rating scale)

    Time frame: 30 min, 6 hr, and 24 hr after procedure

  2. Incidence of nausea and vomiting

    Nausea requiring antiemetics and retching and/or vomiting

    Time frame: Up to 24 hours

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02543411
Lead sponsor
Severance Hospital
Responsible party
So Yeon Kim (Assistant professor, Severance Hospital) — Principal investigator
First posted
Sep 7, 2015
Start date
Sep 2015
Primary completion
Nov 2015
Last update
Dec 15, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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