NCT02235246

Brief Summary

Endoscopic submucosal dissection (ESD) is an effective treatment for early gastric cancer or premalignant lesions in the stomach. ESD enables en bloc resection of gastrointestinal neoplasms, increases the rates of histologically complete resections, and also reduces local recurrence rates. Despite these advantages, ESD is thought to induce various complications. Wellknown ESD-related complications include perforation, postoperative bleeding, or stricture. In addition, minor adverse events after ESD are also commonly noticed. Pain is one of these frequently noticed minor ESD related complications, is the main reason for prolongation of the hospital stay, and is related to patients' compliance; however, there is a tendency to neglect or underestimate post-ESD pain. The causes of pain associated with ESD are thought to be associated with transmural burn or transmural air leak. Some studies have tried to control localized pain during and after ESD using local lidocaine, single dose postoperative intravenous dexamethasone or a transdermal fentanyl patch. Magnesium has been reported to alter the perception and duration of pain and produce important analgesic effects. It is included the suppression of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties of magnesium are believed to stem from regulation of calcium influx into the cell and antagonism of N-methyl-D-aspartate receptors in the central nervous system. Also, magnesium may prolong neuromuscular blockade after administration of neuromuscular blocking drugs, increase sedation and contribute to serious cardiac morbidity. And magnesium as a hypotensive anaesthesia technique supply objectively better operative field, reduction in the duration of surgery and reduced blood loss. There have been no previous trials on the use of magnesium specifically for pain control following ESD. Thus, the purpose of this study was to assess the efficacy of intravenous magnesium for pain relief after ESD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

September 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

September 5, 2014

Last Update Submit

May 8, 2015

Conditions

Gastric Neoplasm

Keywords

perioperative intravenous magnesiumendoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

  • pain score

    Pain score related with endoscopic mucosal resection will be evaluated with numerical rating scale (0 \~ 10) at time of 30 min, 1 hr, 6 hr, and 24 hr after procedure end.

    average 24hours from endoscopic processure

Study Arms (2)

normal saline

EXPERIMENTAL
Drug: Normal saline

magnesium sulfate

ACTIVE COMPARATOR
Drug: Magnesium Sulfate

Interventions

Magnesium SulfateDRUG

magnesium sulfate 50 mg/kg will be administrated during 10 min before anesthetic induction in patients undergoing endoscopic submucosal dissection.

magnesium sulfate
Normal salineDRUG

Normal saline will be administrated during 10 min before anesethetic induction in patients undergoing endoscopic submucosal dissection.

normal saline

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. ASA 1\~2, 2. age of 40- 80 years

You may not qualify if:

  • patients who cannot read,
  • patients refusing the study
  • allergy to magnesium
  • chronic pain
  • chronic abuse of opioid or NSAID
  • neuromuscular block
  • atrioventricular conductance block
  • liver failure,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevrance hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Kim JE, Shin CS, Lee YC, Lee HS, Ban M, Kim SY. Beneficial effect of intravenous magnesium during endoscopic submucosal dissection for gastric neoplasm. Surg Endosc. 2015 Dec;29(12):3795-802. doi: 10.1007/s00464-015-4514-1. Epub 2015 Sep 3.

    PMID: 26335078DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Magnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 9, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

KR(1)