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

NCT ID: NCT02235246

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-02-28

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.

Conditions

Gastric Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

normal saline

Group Type: EXPERIMENTAL

Normal saline

Intervention Type: DRUG

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

magnesium sulfate

Group Type: ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type: DRUG

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

Interventions

Magnesium Sulfate

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

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

Eligibility Criteria

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,

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sevrance hospital

Seoul, Seoul, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 26335078 (View on PubMed)

Other Identifiers

4-2014-0601

Identifier Type: -

Identifier Source: org_study_id