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Use of Lidocaine in Endoscopic Submucosal Dissection

Primary Purpose

Gastric Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lidocaine 1%
Normal saline
Sponsored by
Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Neoplasm

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine group

Control group

Arm Description

Administration of lidocaine 1%

Administration of normal saline

Outcomes

Primary Outcome Measures

Fentanyl consumption during sedation

Secondary Outcome Measures

Pain intensity measured by numerical rating scale
0 = no pain at all and 10 = worst pain imaginable (11-point numerical rating scale)
Incidence of nausea and vomiting
Nausea requiring antiemetics and retching and/or vomiting

Full Information

First Posted
September 2, 2015
Last Updated
December 14, 2015
Sponsor
Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02543411
Brief Title
Use of Lidocaine in Endoscopic Submucosal Dissection
Official Title
Effect of Intravenous Lidocaine During Endoscopic Submucosal Dissection for Gastric Neoplasm
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Severance Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Neoplasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine group
Arm Type
Experimental
Arm Description
Administration of lidocaine 1%
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Administration of normal saline
Intervention Type
Drug
Intervention Name(s)
Lidocaine 1%
Intervention Description
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
Intervention Name(s)
Normal saline
Intervention Description
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 Outcome Measure Information:
Title
Fentanyl consumption during sedation
Time Frame
During sedation, an expected average of 40 minutes
Secondary Outcome Measure Information:
Title
Pain intensity measured by numerical rating scale
Description
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
Title
Incidence of nausea and vomiting
Description
Nausea requiring antiemetics and retching and/or vomiting
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. 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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Use of Lidocaine in Endoscopic Submucosal Dissection

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