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The Effect of Perioperative Intravenous Magnesium on Pain After Endoscopic Submucosal Dissection for Gastric Neoplasm: Prospective Randomized Double-blind Placebo Controlled Study

Primary Purpose

Gastric Neoplasm

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnesium Sulfate
Normal saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Neoplasm focused on measuring perioperative intravenous magnesium, endoscopic submucosal dissection

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. patients who cannot read,
  2. patients refusing the study
  3. allergy to magnesium
  4. chronic pain
  5. chronic abuse of opioid or NSAID
  6. neuromuscular block
  7. atrioventricular conductance block
  8. liver failure,

Sites / Locations

  • Sevrance hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

normal saline

magnesium sulfate

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2014
Last Updated
May 8, 2015
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02235246
Brief Title
The Effect of Perioperative Intravenous Magnesium on Pain After Endoscopic Submucosal Dissection for Gastric Neoplasm: Prospective Randomized Double-blind Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Neoplasm
Keywords
perioperative intravenous magnesium, endoscopic submucosal dissection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal saline
Arm Type
Experimental
Arm Title
magnesium sulfate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
magnesium sulfate 50 mg/kg will be administrated during 10 min before anesthetic induction in patients undergoing endoscopic submucosal dissection.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline will be administrated during 10 min before anesethetic induction in patients undergoing endoscopic submucosal dissection.
Primary Outcome Measure Information:
Title
pain score
Description
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.
Time Frame
average 24hours from endoscopic processure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. ASA 1~2, 2. age of 40- 80 years Exclusion Criteria: 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,
Facility Information:
Facility Name
Sevrance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26335078
Citation
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.
Results Reference
derived

Learn more about this trial

The Effect of Perioperative Intravenous Magnesium on Pain After Endoscopic Submucosal Dissection for Gastric Neoplasm: Prospective Randomized Double-blind Placebo Controlled Study

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