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Use of Lidocaine in Endoscopic Submucosal Dissection

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Yonsei University

Status

Completed

Conditions

Gastric Neoplasm

Treatments

Drug: Lidocaine 1%
Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02543411
4-2014-0933

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

66 participants in 2 patient groups, including a placebo group

Lidocaine group
Experimental group
Description:
Administration of lidocaine 1%
Treatment:
Drug: Lidocaine 1%
Control group
Placebo Comparator group
Description:
Administration of normal saline
Treatment:
Drug: Normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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