NCT02543411

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

2 months

First QC Date

September 2, 2015

Last Update Submit

December 14, 2015

Conditions

Gastric Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Fentanyl consumption during sedation

    During sedation, an expected average of 40 minutes

Secondary Outcomes (2)

  • Pain intensity measured by numerical rating scale

    30 min, 6 hr, and 24 hr after procedure

  • Incidence of nausea and vomiting

    Up to 24 hours

Study Arms (2)

Lidocaine group

EXPERIMENTAL

Administration of lidocaine 1%

Drug: Lidocaine 1%

Control group

PLACEBO COMPARATOR

Administration of normal saline

Drug: Normal saline

Interventions

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

Lidocaine group
Normal salineDRUG

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

Control group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Endoscopic submucosal dissection for the treatments of early gastric neoplasm

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

LidocaineSaline Solution

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 7, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations

KR(1)