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NCT Number: NCT02543411

Use of Lidocaine in Endoscopic Submucosal Dissection

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.

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Key information

Conditions

Gastric Neoplasm Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Endoscopic submucosal dissection for the treatments of early gastric neoplasm

Exclusion criteria

  • Allergy to lidocaine
  • Chronic pain
  • Chronic abuse of opioid or NSAID
  • Atrioventricular conductance block
  • Liver dysfunction
  • Renal dysfunction

Treatment and study plan

Lidocaine 1%

Drug

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

normal saline

Drug

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

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

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

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

  2. Incidence of nausea and vomiting

    Time frame: Up to 24 hours

    Nausea requiring antiemetics and retching and/or vomiting

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Official study title

Effect of Intravenous Lidocaine During Endoscopic Submucosal Dissection for Gastric Neoplasm

Important dates

Study start
2015
Primary completion
2015
First posted
Sep 7, 2015
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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