Home » Trials » SLCTR/2013/016
The effects of epidural magnesium on perioperative treatment in patients undergoing thoracic surgery
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SLCTR Registration Number
SLCTR/2013/016
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
The effects of epidural magnesium on perioperative treatment in patients undergoing thoracic surgery
Public Title of Trial
The effects of epidural magnesium on perioperative treatment in patients undergoing thoracic surgery
Disease or Health Condition(s) Studied
Postoperative pain in thoracic surgery
Scientific Acronym
None
Public Acronym
None
Brief title
Pain management and stress response
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Does epidural magnesium during thoracotomy modulate or diminish cumulative doses of anaesthetics, muscle relaxants and analgetics intra- and postoperatively, modulate neuroendocrine stress response, incidence of perioperative complications and chronic postoperative pain?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Placebo
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
Patients undergoing thoracic surgery will be randomized into 2 groups. The first group will receive continuous epidural infusion of 10%MgSO4. The second group will receive continuous epidural infusion of 0.9% NaCl. During 48 hours postoperatively the first group will receive continuous epidural infusion of local anesthetic, opioid and 10% MgSO4 and the second group continuous epidural infusion of local anesthetic and opioid.
Inclusion criteria
Adult patients, ASA class I-III undergoing elective thoracic surgery
Exclusion criteria
Patients with renal or hepatic failure, patients with neuromuscular disorders, AV block II-III degree, morbidly obese and patients preoperatively treated with opioids or calcium channel blockers
Primary outcome(s)
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1.
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Secondary outcome(s)
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1.
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Target number/sample size
70 patients (35 in each arm)
Countries of recruitment
Croatia
Anticipated start date
2013-04-12
Anticipated end date
2013-08-08
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2013-03-21
Approval number
380-59-10106-13-195/86
Details of Ethics Review Committee
| Name: | Ethics Committee of the Zagreb University Hospital Centre and School of Medicine |
| Institutional Address: | Zagreb, Croatia |
| Telephone: | Not Available |
| Email: | Not Available |
Contact person for Scientific Queries/Principal Investigator
Jana Kogler M.D.
Department of Anesthesiology and Intensive Care, University Hospital Center Zagreb, Joradonovac 104, 10 000 Zagreb, Croatia
0038512385221 0038512421601
jkogler1974@yahoo.com
Contact Person for Public Queries
Jana Kogler M.D.
Department of Anesthesiology and Intensive Care, University Hospital Center Zagreb, Joradonovac 104, 10 000 Zagreb, Croatia
0038512385221 0038512421601
jkogler1974@yahoo.com
Primary study sponsor/organization
Department of Anesthesia and Intensive Care
University Hospital Center Zagreb, Jordanovac 104, 10 000 Zagreb, Croatia
0038512385214 0038512421601
jkogler1974@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
