Use of Lidocaine in Endoscopic Submucosal Dissection

NCT ID: NCT02543411

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine group

Administration of lidocaine 1%

Group Type EXPERIMENTAL

Lidocaine 1%

Intervention Type 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

Control group

Administration of normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type 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

Interventions

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Lidocaine 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

Intervention Type DRUG

Normal 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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So Yeon Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0933

Identifier Type: -

Identifier Source: org_study_id