Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001151325
Ethics application status
Approved
Date submitted
25/07/2017
Date registered
7/08/2017
Date last updated
7/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of neuromuscular monitorings (TOF-Watch SX stabilised in the SL TOF tube versus Philips NMT Module stabilised in Philips Hand Adaptor ) in patients undergoing rhinoplasty or rhinoseptoplasty.
Scientific title
Investigation protocol comparing two quantitative modules for monitoring peroperative neuromuscular transmission in patients undergoing rhinoplasty or rhinoseptoplasty Under general anaesthesic: TOF-Watch SX stabilised in the SL TOF tube versus Philips NMT module stabilised in Philips Hand Adaptor .
Secondary ID [1] 291927 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
patients undergoing rhinoplasty or rhinoseptoplasty under general anaesthesic 303254 0
Condition category
Condition code
Anaesthesiology 302676 302676 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This investigation protocol seeks to compare the results obtained in clinical practice in curarised patients using two monitoring modules currently marketed (in line with EU standards):
The results obtained simultaneously by the Philips Intellivue NMT module (Philips, The Netherlands) on a patient's hand stabilised in Philips Hand Adaptor will be compared with those obtained by the TOF-Watch SX (Organon, The Netherlands) fitted to their other hand also stabilised in the SL TOF tube, an association which has demonstrated the adequacy of its results compared with mechanomyography, the established reference method. The investigation focusses on a cohort of 30 patients aged 18 to 80, classified ASA I or II and undergoing rhinoplasty or rhinoseptoplasty under general anaesthetic. The patient's height, weight, age and sex are recorded in the protocol, as is their dominant hand (left or right) to define the population investigated.
As premedication, the patient receives Alprazolam 0.5 mg an hour before they go to theatre. On arrival in theatre, the patient is conventionally monitored with a saturometer, an electrocardiogram with three or five derivations depending on their antecedents, and their blood pressure is measured non-invasively, scheduled in automatic mode with constant measurements at five-minute intervals.
An intravenous drip (18G catheter) is inserted into their forearm or elbow, for intravenous perfusion of Plasmalyte 500 ml as the first perfusion.
The module to monitor neuromuscular transmission using acceleromyography is connected (non-invasive and non-traumatic), one hand with TOF-Watch SX stabilised in SL TOF tube, the other one with NMT Philips in Philips Hand Adaptor. We observe the criteria for good clinical practice for pharmaco-dynamic investigations as proposed by Fuchs-Buder. The skin is cleaned with diethylether and two ECG skin electrodes are placed along the route of the ulnar nerve on each wrist.
The arm on which the Philips Intellivue NMT module is placed to a hand stabilised in Philips Hand Adaptor (in contrast to a previous trial which was left free of any specific installation as recommended in its user manual), whilst the forearm on which the AMG TOF-Watch SX is placed is positioned in the SL TOF Tube and this is thus considered the reference curarisation monitoring module.
The arms are then placed alongside the body in "spoon"-type arm supports with a thick layer of gel to protect nerve structures.
Once all monitoring modules are in place, the patient is pre-oxygenated using pure oxygen, FiO2 100% at a rate of 8 l/min.
The general anaesthetic is induced with continuous intravenous infusion of Remifentanyl 0.25 gamma/kg/min, and continuous infusion of Propofol 1% to obtain a theoretical plasma concentration of 3 to 4 gamma/cc (Diprifusor Cardinal Health, Basingstoke, UK) and Linisol 2% 1 mg/kg as an intravenous bolus. As soon as the patient loses consciousness, they are manually ventilated.
Now, simultaneously with each NMT monitoring module, we can automatically investigate the supra-maximum stimulation threshold and 100% calibration of initial responses. The amperages determined by the two devices (± 50 mA) are recorded.
Each ulnar nerve is stimulated simultaneously using a Train of Four (4 electric stimulations at 2 Hz, Train of Four, TOF) repeated at 15-second intervals.
Four successive base value measurements for the TOF ratio (T4/T1 ratio) are recorded for each curarisation monitoring module, simultaneously, and their averages determine the reference values before curarisation. We calculate 90% of this base value to determine the neuromuscular blocking recovery threshold for each monitoring module using the following formula:
Normalised TOF ratio 90% = sum of 4 TOF ratio × 9/40 with a result rounded up.
With the baseline determined, the patient is curarised with administration of rocuronium 0.5 mg/kg. The theatre time is noted as the reference time (hh:mm:ss). Non-invasive automatic blood pressure measurement is suspended during the neuromuscular blocking induction phase so as not to limit the distribution of the Rocuronium in either of the two arms.
So we expect to each a state of deep curarisation, with a TOF count of 0. Again, the exact time is recorded when the TOF count of 0 is reached using the TOF-Watch and when it is reached using the Philips NMT (onset duration).
Then non-invasive blood pressure measurement is reactivated.
The patient is then conventionally intubated, eye protection is put in place, the tube is fitted and assisted ventilation in "Controlled volume" mode is begun, followed by the surgical equipment.
Post-Tetanic-Count (PTC: automatic stimulation sequence including 50 Hz tetanic stimulation for 5 seconds adapted to monitor deep neuromuscular blocking) is then measured with each monitoring module at the same time (hours - minutes -seconds noted). After a free period of 3 minutes, TOF stimulation mode is launched every 15 seconds.
Anaesthesia is maintained with continuous intravenous administration of Remifentanyl 0.15 gamma/kg/min and Propofol 1% in AIVOC mode with a target plasma concentration of 2 to 4 gamma/cc. Neither Magnesium, nor halogenated vapour, nor a further bolus of rocuronium is administered (to prevent potentialisation of neuromuscular blocking by these agents).
We then continuously observe via the TOF spontaneous recovery of neuromuscular blocking with successive, simultaneous measurements (every 15 seconds) using the two curarisation monitoring modules.
The investigation seeks to confirm (or otherwise) the similarity between the results obtained using each monitoring module positioned in the SL TOF tube.

Intervention code [1] 298046 0
Diagnosis / Prognosis
Comparator / control treatment
Neuromuscular monitoring comparison : Philips NMT module stabilised in Philips Hand Adaptor compared with TOF-Watch SX stabilised in SL TOF tube (considered the reference).
Control group
Active

Outcomes
Primary outcome [1] 302884 0
Initial TOF ratios are recorded with 4 successive measurements before rocuronium is administrered. The average of the 4 measurements determines the initial Baseline. These baselines obtained by the Philips NMT module and the TOF-Watch SX are compared for each patient.
Timepoint [1] 302884 0
As soon as the patient loses consciousness, they are manually ventilated. Simultaneously with each NMT monitoring module, we can automatically investigate the supra-maximum stimulation thresold and 100% calibration of initial responses. The ampérages determined by the two devices (+/- 50 mA) are recorded. Each ulnar nerve is stimulated simultaneously, repeated at 15-second intervals for the duration of the surgery.
Secondary outcome [1] 337333 0
TOF ratio 90% are recorded on each device and they are compared.
Timepoint [1] 337333 0
As soon as the patient loses consciousness, they are manually ventilated. Simultaneously with each NMT monitoring module, we can automatically investigate the supra-maximum stimulation thresold and 100% calibration of initial responses. The ampérages determined by the two devices (+/- 50 mA) are recorded. Each ulnar nerve is stimulated simultaneously, repeated at 15-second intervals for the duration of the surgery.

Eligibility
Key inclusion criteria
- aged 18 to 80
- classified ASA I or II
- undergoing rhinoplasty or rhinoseptoplasty under general anaesthetic
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- pregnant and breastfeeding women,
- patients with renal or hepatic insufficiency,
- patients with neurological deficit,
- patients with a suspected allergy to the drugs used in the protocol or receiving treatment which will interfere with neuromuscular transmission

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Baseline analysis: definition and comparison of levels and repeatability factors.
Initial TOF ratios are recorded with 4 successive measurements before rocuronium is administered. The average of the 4 measurements determines the initial baseline. These baselines obtained by the Philips NMT module and the TOF-Watch SX are compared for each patient using a Wilcoxon Rank Sum test. Repeatability factors (1.96v2 SD) are compared using a z test, a low factor indicating little variability between consecutive measurements. P<0.05 is considered significant.
The same comparative analysis is conducted once a final baseline has stabilised, ensured with administration of 100 mg of Sugammadex after recovery of a normalised TOF ratio of 90%. The initial and final baselines will be compared using a Wilcoxon Rank Sum test. P<0.05 is considered significant.

Analysis of neuromuscular blocking recovery profiles: performance of the Philips NMT module compared with the TOF-Watch SX (considered the reference).
In the different neuromuscular blocking scores (PTC, TOF count 2, TOF ratio 50%, TOF ratio 90% and normalised TOF ratio 90%), 4 consecutive, simultaneous measurements are recorded on each device when the value concerned is reached on the TOF-Watch SX, but also when the TOF ratio 90% (gross and normalised) is reached with the Philips NMT module. These results are compared using a Wilcoxon Rank Sum test, p<0.05 significant. The bias and the agreement limits of the two devices with different scores considered are also determined using the method described by Bland and Altman.

Sample determination is considered in light of recovery of the TOF ratio 90%, the critical safety threshold for orotracheal extubation.
Considering a risk alpha of 0.05 and a power 1-beta of 95, and for variability (DS) observed on a pre-series of 17.5%, we must recruit 30 patients so that a difference of 10% using the two measurements does not escape us.
The statistical analyses were carried out with SPSS Registered Trademark 15.0 statistical software (SPSS Inc., Chicago, Ill) and G*Power 3.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/07/2017
Date of last participant enrolment
Anticipated
27/09/2017
Actual
Date of last data collection
Anticipated
28/09/2017
Actual
Sample size
Target
30
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 9092 0
Belgium
State/province [1] 9092 0
Namur

Funding & Sponsors
Funding source category [1] 296432 0
Hospital
Name [1] 296432 0
CHU UCL Namur - Mont-Godinne
Country [1] 296432 0
Belgium
Primary sponsor type
Hospital
Name
CHU UCL Namur - Mont-Godinne
Address
Gaston Therasse Street, 1
5530 Yvoir
Country
Belgium
Secondary sponsor category [1] 295385 0
None
Name [1] 295385 0
Address [1] 295385 0
Country [1] 295385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297661 0
Ethics Committe of CHU UCL Namur
Ethics committee address [1] 297661 0
Ethics committee country [1] 297661 0
Belgium
Date submitted for ethics approval [1] 297661 0
05/05/2017
Approval date [1] 297661 0
11/07/2017
Ethics approval number [1] 297661 0
B039201732792

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

Contacts
Principal investigator
Name 74742 0
Dr Dubois Virginie
Address 74742 0
CHU UCL Namur Godinne
Gaston Therasse Street, 1
5530 Yvoir
Country 74742 0
Belgium
Phone 74742 0
+32 81 423910
Fax 74742 0
Email 74742 0
[email protected]
Contact person for public queries
Name 74743 0
Fostier Guillaume
Address 74743 0
CHU UCL Namur Godinne
Gaston Therasse Street, 1
5530 Yvoir
Country 74743 0
Belgium
Phone 74743 0
+32 81 423911
Fax 74743 0
Email 74743 0
[email protected]
Contact person for scientific queries
Name 74744 0
Dubois Philippe
Address 74744 0
CHU UCL Namur Godinne
Gaston Therasse Street, 1
5530 Yvoir
Country 74744 0
Belgium
Phone 74744 0
+32 81 423929
Fax 74744 0
Email 74744 0
[email protected]

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

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