The use of highadose melatonin in liver resection is safe: first clinical experience

• Published in: Journal of pineal research 2011-05, Vol.50 (4), p.381-388
• Main Authors: Nickkholgh, Arash, Schneider, Heinz, Sobirey, Michael, Venetz, Werner P, Hinz, Ulf, Pelzl, Le H, Gotthardt, Daniel N, Cekauskas, Albertas, Manikas, Martynas, Mikalauskas, Saulius, Mikalauskene, Laura, Bruns, Helge, Zorn, Markus, Weigand, Markus A, Buchler, Markus W, Schemmer, Peter
• Format: Article
• Language: English
• ISSN: 0742-3098; 1600-079X
• DOI: 10.1111/j.1600-079X.2011.00854.x

Experimental data suggest that melatonin decreases inflammatory changes after major liver resection, thus positively influencing the postoperative course. To assess the safety of a preoperative single dose of melatonin in patients undergoing major liver resection, a randomized controlled double-blind pilot clinical trial with two parallel study arms was designed at the Department of General and Transplantation Surgery, Ruprecht-Karls-University, Heidelberg. A total of 307 patients, who were referred for liver surgery, were screened. One hundred and thirteen patients, for whom a major liver resection ( greater than or equal to 3 segments) was scheduled, were eligible. Sixty-three eligible patients refused to participate, and therefore, 50 patients were randomized. A preoperative single dose of melatonin (50mg/kg BW) dissolved in 250mL of milk was administered through the gastric tube after the intubation for general anesthesia. Controls were given the same amount of microcrystalline cellulose. Primary endpoint was safety. Secondary endpoints were postoperative complications. Melatonin was effectively absorbed with serum concentrations of 1142.8+/-7.2ng/mL (mean+/-S.E.M.) versus 0.3+/-7.8ng/mL in controls (P