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

May 8, 2015 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: normal saline
Drug: Normal saline
Normal saline will be administrated during 10 min before anesethetic induction in patients undergoing endoscopic submucosal dissection.
Active Comparator: magnesium sulfate
Drug: Magnesium Sulfate
magnesium sulfate 50 mg/kg will be administrated during 10 min before anesthetic induction in patients undergoing endoscopic submucosal dissection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: average 24hours from endoscopic processure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 5, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 8, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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