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Trial registered on ANZCTR


Registration number
ACTRN12615000838516
Ethics application status
Approved
Date submitted
18/06/2015
Date registered
11/08/2015
Date last updated
4/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of depth of muscle relaxation to improve performance of percutaneous ablation of liver tumours
Scientific title
Comparing depth of muscle relaxation in the performance of percutaneous ablation of liver tumours
Secondary ID [1] 289608 0
Nil known
Universal Trial Number (UTN)
U1111-1170-4634
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver tumour (primary or secondary) 295161 0
Condition category
Condition code
Anaesthesiology 295398 295398 0 0
Anaesthetics
Cancer 295399 295399 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-center, prospective, double-blinded, randomized controlled trial involving a sample size of 100 patients (50 per group) undergoing CT-guided radiofrequency ablation of primary and secondary liver tumours in the Department of Biomedical Imaging, University Malaya Medical Centre.

All patients who are eligible to enroll will be given a patient information sheet and have their consent taken prior to procedure.

There will be 2 groups in this study:
Group (1) deep neuromuscular blockade (DMB) will receive 1.0mg/kg IV Rocuronium bolus during induction followed by infusion to maintain post-tetanic count (PTC) of 1 or 2. Initial pump rate will be set at 0.6mg/kg/hr and adjusted accordingly by increments of 0.1 to maintain PTC of 1 or 2.

Group (2) moderate neuromuscular blockade (MMB) will receive 0.5mg/kg IV Atracurium bolus during induction followed by infusion to maintain train-of-four count (TOF) of 1 or 2. Initial pump rate will be set at 0.3mg/kg/hr and adjusted accordingly by increments of 0.1 to maintain TOF count of 1 or 2.

Further boluses of 10mg Rocuronium or Atracurium will be given if requested by the interventional radiologist and documented. All patients will be intubated with cuffed Portex ETT and anaesthesia maintained with a balanced technique to achieve MAC of 1.0-1.3. They will be ventilated with intermittent positive pressure ventilation using pressure control to achieve a tidal volume of not more than 7mls/kg and ETCO2 of 35-40 mmHg. Ventilation will be intermittently suspended at varying lengths of time when required by the radiologist (only allowed if patient is stable with SpO2 of at least 97%). Suspension of ventilation must resume should the oxygen saturation starts to drop below 96% or >4% from baseline.

Depth of neuromuscular blockade will be monitored with TOF-Watch (Registered Trade Mark) Organon (Ireland) Ltd which will be calibrated prior to use. After completion of procedure, infusions of drugs in both Groups 1 and 2 will be terminated. Group (1) will be reversed with IV Sugammadex 4mg/kg while Group (2) with IV Neostigmine 0.05mg/kg and IV Atropine 0.02mg/kg. Patients will be extubated when TOF ratio becomes 0.9 or more and will be monitored in the recovery area for at least half an hour.
If patients cannot be extubated, reasons will be documented.

Analgesics such as 0.05 - 0.1 mg/kg IV morphine or 40 mg IV Parecoxib will be given after induction with additional boluses of analgesia in the recovery after extubation based on pain scores.
Dexamethasone 4mg will be given as anti emetics when required after induction.

Follow up with records and phone call at 1 year after tumor percutaneous ablation procedure
Intervention code [1] 291940 0
Treatment: Drugs
Comparator / control treatment
Moderate depth of muscle relaxation during general anaesthesia (TOF 1-2)(Group 2, MMB)
Control group
Active

Outcomes
Primary outcome [1] 295209 0
To assess the difference in the mean of liver excursion (in mm) during the procedure between deep neuromuscular blockade (DMB) in Group 1 and moderate neuromuscular blockade (MMB) in Group 2.
Amplitude of liver excursion will be measured (in milimetres) during baseline CT and post-procedure multiphasic contrast-enhanced CT and recorded. The number and site of lesions will also be recorded in the data collecting form to judge the difficulty of performing the procedure due to anatomical constraints.
Timepoint [1] 295209 0
CT scans at baseline, during the RFA procedure and immediately following its completion.
Primary outcome [2] 295483 0
Evaluating the ease of performing the RFA in liver tumours on a 5-point scale by the interventional radiologist.
Timepoint [2] 295483 0
At the end of procedure
Secondary outcome [1] 315074 0
Haemodynamic parameters such as heart rate, ECG recordings, blood pressure measurements using an automated pressure cuff will be recorded during procedure
Timepoint [1] 315074 0
Every 10 minutes during the radiofrequency procedure, at the end and recovery period
Secondary outcome [2] 315676 0
Ventilator variables such as tidal volume, peak airway pressure, respiratory rate, end-tidal CO2 which are automatically recorded on the ventilator device
Timepoint [2] 315676 0
Every 10 minutes during the radiofrequency procedure
Secondary outcome [3] 315677 0
The duration of procedure
Timepoint [3] 315677 0
From the start until the end of procedure
Secondary outcome [4] 315678 0
Complication rates such as bleeding, hypotension, respiratory problems (pneumothorax, haemothorax, pleural effusion), unplanned ICU admission or adverse events in post anaesthetic care unit (nausea, vomiting, severe pain)
Timepoint [4] 315678 0
During the ablation procedure, at the end and within first 24 hours
Secondary outcome [5] 315679 0
Patient's satisfaction score of the treatment using a numerical scoring system (1, extremely dissatisfied to 10, extremely satisfied)
Timepoint [5] 315679 0
Post procedure Day 1
Secondary outcome [6] 315680 0
Length of hospital stay
Timepoint [6] 315680 0
After procedure until discharge
Secondary outcome [7] 325375 0
1 year mortality
Assessed through medical records and phone calls
Timepoint [7] 325375 0
1 year post procedure
Secondary outcome [8] 325376 0
Tumour recurrence rate after 1 year of procedure through medical records and phone calls
Timepoint [8] 325376 0
1 year post procedure

Eligibility
Key inclusion criteria
- ASA 1 to 3
- Age between 18 to 75 years old
- Confirmed diagnosis of primary or secondary liver tumours and planned for elective percutaneous ablation by primary team and radiologist.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Refusal to participate in this study by patient or the legal representative
2. Any contraindications to the RFA procedure
3. Any contraindications to general anaesthesia
4. Any contraindications to any of the drugs used such as
i) severe renal impairment for rocuronium and sugammadex
ii) allergy
5. Pregnant or breastfeeding patients

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)
A research assistant will organize the randomization for 1-100 subjects, label the group numbers 1 or 2 and seal the opaque envelopes bearing the respective subject index numbers before the start of the trial.

Another person will screen and obtain consent from eligible subjects. The sealed envelopes will be opened prior to starting the RFA procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software generated randomisation table
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 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation was performed using OpenEpi Version 3.03 open source software. Sample size required to achieve at least 80% power (1-beta) at alpha level 5% (a) is 86 (43 per group). Estimation was based on mean and standard deviation differences of 1.3mm between the 2 groups. After considering 15% drop out rate, total sample required is 100 (50 per group).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2015
Actual
17/06/2015
Date of last participant enrolment
Anticipated
31/07/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6950 0
Malaysia
State/province [1] 6950 0
Petaling Jaya

Funding & Sponsors
Funding source category [1] 291400 0
University
Name [1] 291400 0
Postgraduate research grant from University of Malaya, Malaysia
Country [1] 291400 0
Malaysia
Primary sponsor type
University
Name
University Malaya
Address
University Malaya
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 290075 0
None
Name [1] 290075 0
Address [1] 290075 0
Country [1] 290075 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292948 0
Medical Ethics Committee University Malaya Medical Centre
Ethics committee address [1] 292948 0
Ethics committee country [1] 292948 0
Malaysia
Date submitted for ethics approval [1] 292948 0
23/01/2015
Approval date [1] 292948 0
14/06/2015
Ethics approval number [1] 292948 0
MECID.NO: 20151-930

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

Contacts
Principal investigator
Name 57514 0
Dr Pui-San Loh
Address 57514 0
University Malaya Medical Centre,
Jalan Universiti,
50603 Kuala Lumpur,
Malaysia
Country 57514 0
Malaysia
Phone 57514 0
+60379492052
Fax 57514 0
Email 57514 0
lohps@um.edu.my
Contact person for public queries
Name 57515 0
Naeema S.Masohood
Address 57515 0
University Malaya Medical Centre
Jalan Universiti,
50603 Kuala Lumpur,
Malaysia
Country 57515 0
Malaysia
Phone 57515 0
+60379492052
Fax 57515 0
Email 57515 0
naeema@ummc.edu.my
Contact person for scientific queries
Name 57516 0
Pui-San Loh
Address 57516 0
University Malaya Medical Centre
Jalan Universiti,
50603 Kuala Lumpur,
Malaysia
Country 57516 0
Malaysia
Phone 57516 0
+60379492052
Fax 57516 0
Email 57516 0
lohps@um.edu.my

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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