Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001142527
Ethics application status
Approved
Date submitted
22/09/2015
Date registered
27/10/2015
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study investigating the effect of deep neuromuscular blockade on recovery after laparoscopic (keyhole) colorectal surgery.
Scientific title
A blinded randomised controlled trial to determine if the provision of deep neuromuscular blockade, relative to standard neuromuscular blockade, in patients undergoing laparoscopic colorectal surgery, leads to an improvement in patient outcomes, for example, quicker return of bowel function, less pain, nausea and vomiting, thus resulting in a quicker discharge from hospital
Secondary ID [1] 287525 0
Nil
Universal Trial Number (UTN)
U1111-1174-7890
Trial acronym
ERAS and deep neuromuscular blockade
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal surgery 296290 0
Condition category
Condition code
Surgery 296566 296566 0 0
Other surgery
Anaesthesiology 296567 296567 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292918 0
Treatment: Drugs
Intervention code [2] 292919 0
Treatment: Other
Comparator / control treatment
Standard neuromuscular blockade, using rocuronium as the neuromuscular blocking drug at a dose of 0.6 mg/kg (actual body weight) at induction. There is no requirement for nerve stimulator monitoring, and although its use is not prohibited, the use of a tetanic stimulation is. As per standard practice, further doses of rocuronium (10 mg), may be given at the discretion of the anaesthetist either time based, or noted change in capnography and ventilatory requirements. At the completion of laparoscopic surgery (prior to suturing of the port sites), neostigmine (2.5 mg) and glycoprrolate (400 mcg), is given intravenously. Adherence to this protocol will be determined by analysis of the anaesthetic record.
Control group
Active

Outcomes
Primary outcome [1] 296185 0
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.
Timepoint [1] 296185 0
The composite primary outcome will be assessed daily from day 1 post surgery, until hospital discharge.
Primary outcome [2] 296247 0
Re-admission rates
Timepoint [2] 296247 0
The readmission rate will be determined from the time of discharge from hospital until 30 days post the initial admission date.
Primary outcome [3] 296248 0
Mortality
Timepoint [3] 296248 0
Mortality will be scored from the time of admission to hospital, until 30 days post the initial admission. Mortality will be determined from hospital records or a follow-up telephone call at 30 days post initial hospital admission.
Secondary outcome [1] 317730 0
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.
Timepoint [1] 317730 0
For the operating theatre time, this will be determined from the time the patient arrives in theatre, to the time that the patient is discharged to the post anaesthesia care unit (PACU). For the total length of hospital admission and cost of care, this will be determined from the time that the patient is admitted to hospital until the time of discharge from the hospital.
Secondary outcome [2] 317731 0
Surgical operative condition optimisation as measured by intraoperative reportables by surgeons and anaesthetists.
Timepoint [2] 317731 0
Completion of surgery

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential study participants will be identified at the time of consenting for surgery. It is a standard process for patients to be invited to participate in research. For the purposes of this study, having discussed the usual procedures of surgery, the surgeon will ask the potential participant if they would be happy to be contacted by the study nurse to discuss the study. Due to the potential for conflict of interest and coercion, the treating surgeon will not be involved in consenting for the study or formal recruitment. If permission is given, the potential participant’s details will be provided to the study nurse.

On receipt of the potential participant’s details and consent to approach, the study nurse will make contact to discuss the study and send the Patient Information Sheet (PIS) outlining the study. Interpreters will be used for these consultations, as required. The information will not be translated in writing as is Northern Health policy in the provision of peri-operative information but will be explained in the appropriate language where required.

An appointment will be made by the study nurse to discuss the study with interested potential participants at the time of another hospital appointment using interpreters where needed. At this consultation, questions will be answered and formal written consent obtained. The study nurse will be backed up by the Investigators to ensure potential participants are confident with their decision to take part.

Willingness of the individual to take part will be conveyed to the investigators who will co-ordinate the admission date and study participation. Entry into the study will be recorded in the Clinical Patient File.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be via computer generated numbers, which will be sealed in opaque, sequentially numbered envelopes. A total of 40 patients will be recruited, 20 patients to each arm of the trial, these being deep neuromuscular blockade or standard neuromuscular blockade. After randomization, participants will be identified for study purposes by a study code, the master list of which will be kept in a single location with access only by the research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot study, formal sample size estimation has not been calculated.

Data analysis will be performed with the assistance of a statistician.
Descriptive statistics will be used to look at the overall and individual groups.
Chi squared and Fischer’s exact will be used for comparison of categoric data.
Depending on normality testing, parametric and non-parametric tests will be used where appropriate for continuous data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/11/2015
Actual
12/02/2016
Date of last participant enrolment
Anticipated
26/10/2018
Actual
15/05/2018
Date of last data collection
Anticipated
Actual
14/06/2018
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4381 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 10603 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 292095 0
Other
Name [1] 292095 0
Northern Health Small Research Grant
Country [1] 292095 0
Australia
Primary sponsor type
Individual
Name
Darren Lowen
Address
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 290774 0
Individual
Name [1] 290774 0
Karen Barclay
Address [1] 290774 0
Acting Head of the Academic Surgical Unit
Northern Centre for Health Education and Research (NCHER)
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country [1] 290774 0
Australia
Other collaborator category [1] 278634 0
Individual
Name [1] 278634 0
Jun Keat Chan
Address [1] 278634 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country [1] 278634 0
Australia
Other collaborator category [2] 278635 0
Individual
Name [2] 278635 0
Mark Tacey
Address [2] 278635 0
Northern Clinical Research Centre
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country [2] 278635 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293582 0
Northern Health HREC
Ethics committee address [1] 293582 0
Ethics committee country [1] 293582 0
Australia
Date submitted for ethics approval [1] 293582 0
Approval date [1] 293582 0
24/08/2015
Ethics approval number [1] 293582 0
HREC/15/NH/20

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60542 0
Dr Darren Lowen
Address 60542 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 60542 0
Australia
Phone 60542 0
+61402832336
Fax 60542 0
Email 60542 0
[email protected]
Contact person for public queries
Name 60543 0
Darren Lowen
Address 60543 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 60543 0
Australia
Phone 60543 0
+61402832336
Fax 60543 0
Email 60543 0
[email protected]
Contact person for scientific queries
Name 60544 0
Darren Lowen
Address 60544 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 60544 0
Australia
Phone 60544 0
+61402832336
Fax 60544 0
Email 60544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Data will be available immediately following publication, ending 7 years following main results publication
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator, in addition to approval by ethics and local governance


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.