Pilot study investigating the effect of deep neuromuscular blockade on recovery after laparoscopic (keyhole) colorectal surgery.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2015
INTERVENTION: The standard of perioperative care for colorectal surgery at The Northern Hospital, Epping, Victoria, includes participation in an Enhanced Recovery After Surgery (ERAS) programme which is a multi‐modal schema for optimization shown to improve outcomes and reduce length of stay. We wish to determine if the addition of deep neuromuscular blockade for the duration of laparoscopic colorectal surgery, further improves patient outcomes. The initial dose of rocuronium is 1.2 mg/kg (actual body weight). A nerve stimulator will be used for the entirety of the procedure, to ensure that the post‐tetanic count remains between 0‐1. This will be obtained by a train of four count every 20 seconds. If any counts are obtained a further dose of 10 mg rocuronium will be given. In addition, every 15 minutes a tetanic stimulation will be given and if the post‐tetanic count is greater than 1, then a further 10 mg of rocuronium will be given. At the completion of laparoscopic surgery (prior to suturing of the port sites), sugammadex is given at a dose of 4 mg/kg. Both rocuronium and sugammadex are given intravenously. Adherence to this protocol will be determined by analysis of the anaesthetic record which will have the post‐tetanic count documented at 15 minute intervals. CONDITION: Colorectal surgery PRIMARY OUTCOME: Mortality Post operative outcome (a composite of nausea and vomiting, pain, time for passage of first flatus). Post operative nausea and/or vomiting will be assessed by use of a postoperative nausea and vomiting intensity scale, modified from Wengritzky et al., Development and validation of a postoperative nausea and vomiting intensity scale. BJA 104(2), 158‐66, 2010. Time for passage of first flatus will be assessed by asking the patient directly if they have passed flatus. Pain will be assessed by a numerical pain rating scale bounded by 0 at one end and 10 at the other end. Re‐admission rates SECONDARY OUTCOME: Economic viability of the use of deep neuromuscular blockade as measured by operative time, length of stay and cost of care. The operative time and length of hospital admission will be determined from a review of the hospital records. The cost of care will be determined with reference to the following estimated costs: ; Theatre cost is $5,500 per session, with one session being 4 hours. ; The cost of an intensive care bed is $4,600.00 per day. ; The cost of a ward bed is $500.00 per day. Surgical operative condition optimisation as measured by intraoperative reportables by surgeons and anaesthetists. INCLUSION CRITERIA: All patients greater than or equal to 18 years old, requiring laparoscopic colorectal surgery expected to last a minimum of 2 hours and deemed to be medically competent to make informed decisions for themselves.
Epistemonikos ID: 01ed9d4038891cf1dd715ceb051122a2893e0aae
First added on: Aug 23, 2024