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

Gastric Neoplasm Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235246
• Other study ID #: 4-2014-0601
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2014
• Last updated: May 8, 2015
• Start date: October 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastric Neoplasm
• Stomach Neoplasms

Intervention

Drug:
• Magnesium Sulfate
magnesium sulfate 50 mg/kg will be administrated during 10 min before anesthetic induction in patients undergoing endoscopic submucosal dissection.
• Normal saline
Normal saline will be administrated during 10 min before anesethetic induction in patients undergoing endoscopic submucosal dissection.

Locations

Country	Name	City	State
Korea, Republic of	Sevrance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No