• Danish medical journal · Oct 2015

    Randomized Controlled Trial Comparative Study

    Neuromuscular blockade for improvement of surgical conditions during laparotomy: protocol for a randomised study.

    • Matias Vested Madsen, Susanne Scheppan, Peter Kissmeyer, Emilie Mørk, Jacob Rosenberg, and Gätke Mona Ring MR.
    • matias.vested.madsen@regionh.dk.
    • Dan Med J. 2015 Oct 1; 62 (10): A5139.

    IntroductionDuring laparotomy, surgeons frequently experience difficult surgical conditions if the patient's abdominal wall or diaphragm is tense. This issue is particularly pertinent while closing the fascia and placing the intestines into the abdominal cavity. Establishment of a deep neuromuscular blockade (NMB), defined as a post-tetanic-count (PTC) of 0-1, paralyses the abdominal wall muscles and the diaphragm. We hypothesised that deep NMB (PTC 0-1) would improve surgical conditions during upper laparotomy as compared to standard NMB with bolus administration.MethodsThis is an investigator-initiated, assessor- and patient-blinded, randomised study. A total of 128 patients scheduled for elective upper laparotomy will be included and randomised to either continuous deep NMB or standard NMB defined as bolus administrations. Surgical conditions are evaluated using a five-point rating scale every 30 min. Primary outcome is the average score for a patient's surgical condition. Secondary outcomes are, among others, surgical rating score during fascial closure, wound dehiscence, wound infection requiring surgical drainage and incisional hernia at the six-month follow-up.ConclusionsThis randomised, double-blinded study investigates potential effects of deep NMB on surgical conditions and patient outcomes during elective laparotomy.FundingThe study is funded in part by a research grant from the Investigator Initiated Studies Program of Merck Sharp & Dohme Corp.Trial RegistrationNCT02140593.

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