Introduction: During 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.
Methods: This 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.
Conclusions: This randomised, double-blinded study investigates potential effects of deep NMB on surgical conditions and patient outcomes during elective laparotomy.
Funding: The study is funded in part by a research grant from the Investigator Initiated Studies Program of Merck Sharp & Dohme Corp.
Trial registration: NCT02140593.