None listed
Conditions
Brief summary
A recent meta-analysis of 13 randomised controlled trials involving 1910 patients has shown that the application of a bundle of care, as part of the enhanced recovery after surgery (ERAS), relative to standard surgical care, results in a significant decrease in the length of hospital stay and overall complication rates (Zhuang et al. 2013). Apart from associated benefits to the patient in terms of quicker return of normal function and less complication rates, there are significant economic implications as well. Current practice at The Northern Hospital is to provide ERAS to all surgical patients undergoing colorectal surgery. The provision of deep neuromuscular blockade, relative to standard neuromuscular blockade has been shown to improve surgical conditions in laparoscopic surgery (Blobner, et al. 2015; Madsen et al. 2015) and to decrease post-operative pain (Hua et al. 2014). To date, no trials have been conducted to determine whether the use of deep neuromuscular blockade to patients having laparoscopic colorectal surgery and being managed with the ERAS bundle of care, leads to further improvements in patient outcomes, in particular, quicker return of bowel function and reduced length of hospital stay. In addition, it is likely that deep neuromuscular blockade for the duration of surgery will minimise the possibility of trauma to surrounding tissues and reduce surgical operating time, with its associated economic implications.
Interventions
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 weigh
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.
Sponsors
Darren Lowen
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Patients less than 18 years old Patients having laparoscopic colorectal surgery which is expected to last less than 2 hours. Patients who have an appointed legal guardian for medical decisions.
Outcome results
None listed