The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001700123
Ethics application status
Approved
Date submitted
26/08/2019
Date registered
3/12/2019
Date last updated
3/12/2019
Date data sharing statement initially provided
3/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title

Laryngeal microsurgery under deep neuromuscular block
Scientific title

Laryngeal microsurgery under general anesthesia and high frequencies jet ventilation with deep neuromuscular block or without block: how many people change the groups if surgical conditions are inacceptables
Secondary ID [1] 298818 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neuromuscular relaxation 313771 0
microsurgery of vocal cord. 315362 0
Condition category
Condition code
Anaesthesiology 312176 312176 0 0
Anaesthetics
Surgery 312178 312178 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are randomized in two group using minimization

For both groups patients are in dorsal position with classical monitoring.
Preoxygenation
Local of glottis 2mg/kg lidocaine
Ventilation with high frequencies jet ventilation driving pressure between 1.5 and 3 bar, respiratory rate 150/min and report I/T 30%
Surgeons will not be aware of the group to which the patient belongs.
Automatic and continuous recording of vital parameters by Philips monitoring.
In particular, monitoring of neuromuscular function by the NMT module (Acceleromyography by hand with TOF-tube: calibration, supra-maximal stimulation of the ulnar nerve by train-of-four (TOF) every 15 seconds and recording of muscle responses in the protocol of anesthesia according to the recommendations of the literature

Group non curare, anesthesia induction
1. lidocaine 1mg/kg intravenous bolus
2. remifentanyl 0.5 µg/kg/min at the start and 0.15 µg/kg/min during the surgery continuous intravenous
3. propofol mode Target controlled intravenous anaesthesia to adapt according to the depth of anesthesia
4. solumedrol 2mg/kg bolus intravenous
After the disappearance of the ciliary reflex and spontaneous ventilation, an assisted manual ventilation test is performed:

The patient is manually ventilated until it is deep enough. Bi-spectral index <60.
Placement of eye protection. The surgeon exposes the glottal in apnea and evaluates its facility: easy, difficult or inexposable + duration of installation and his vision of vocal cords: o, ¼ post, ½ post, ¾ post or entire. With the installation of the laryngoscope performed, the surgeon places the Mayne-Remacle metal catheter in infraglottic and the high frequency type ventilation starts:
The quality of the operating conditions will be evaluated from the first visualization of the operative field and every 5 minutes in different ways:

- Evaluation of the operating conditions by the surgeon (4 grades excellent, acceptable, to improve and unacceptable).
An unacceptable operating condition in the group will require improvement of analgesia (increase of remifentanyl concentration by 0.15 ± 0.25 µg/kg/min), anesthesia (increase of propofol concentrations) and if conditions remain unacceptable to curarise rocuronium 0.6mg/kg.
- Cough within 5 min: present / absent
- Vocal cords position (abduction, adduction)
- Vocal cords movement during the 5 minutes: yes-no.
- Measurement of the glottal surface via the same optics (0) for all procedures.
Calibrated measurement via the use of a palpator allowing a perfectly objective measurement.
-SpO2 every 5 minutes.
The continuous infusion of remifentanyl is stopped 5 minutes before the end of the procedure. The metal catheter is removed at the end of the surgical procedure and at the same time the propofol administration is stopped. Assisted manual ventilation is used to reduce end tidal CO2 <45 and allow the patient to recover his spontaneous rythm.
Intervention code [1] 315088 0
Treatment: Drugs
Comparator / control treatment
Curare group:
1. lidocaine 1mg/kg intravenous bolus
2. remifentanyl 0.5 µg/kg/min at the start and 0.15 µg/kg/min during the surgery continuous intravenous
3. propofol mode target controlled intravenous anaesthesia to adapt according to the depth of anesthesia
4. solumedrol 2mg/kg bolus intravenous
After the disappearance of the ciliary reflex and spontaneous ventilation, an assisted manual ventilation test is performed:
5. Rocuronium 0,6 mg/kg bolus intravenous and other bolus in order to keep the patient in deep neuromuscular block ( post tetanic count 1-5) throughout the surgical procedure

The patient is manually ventilated until it is deep enough. Bi-spectral index <60 and obtention of a deep neuromuscular block.
Placement of eye protection. The surgeon exposes the glottal in apnea and evaluates its facility: easy, difficult or inexposable + duration of installation and his vision of vocal cords: o, ¼ post, ½ post, ¾ post or entire. With the installation of the laryngoscope performed, the surgeon places the Mayne-Remacle metal catheter in infraglottic and the high frequency type ventilation starts:
The quality of the operating conditions will be evaluated from the first visualization of the operative field and every 5 minutes in different ways:

- Evaluation of the operating conditions by the surgeon (3 grades excellent, to improve and unacceptable).
An unacceptable operating condition require to act at the level of analgesia (increase the concentration of remifentanyl 0.25µg/kg/min) and anesthesia (increase the concentrations of propofol).
- Cough within 5 min: present / absent
- Vocal cords position (abduction, adduction)
- Vocal cords movement during the 5 minutes: yes-no.
- Measurement of the glottal surface via the same optics (0) for all procedures.
Calibrated measurement via the use of a palpator allowing a perfectly objective measurement.
-SpO2 every 5 minutes.

At the end of surgery, the continuous infusion of remifentanyl is stopped 5 minutes before the end of the procedure. The metal catheter is removed at the end of the surgical procedure and at the same time the continuous infusion of propofol is stopped. The patient is decurarized with Sugamadex 4mg / Kg to obtain a train of four ratio> 90%. Assisted manual ventilation is used to reduce end tidal CO2 <45 and allow the patient to recover his spontaneous rythm.

Control group
Active

Outcomes
Primary outcome [1] 320812 0
The number of patients passing from the group without curare to the group curare
Timepoint [1] 320812 0
at every moment during the surgery, if surgical conditions become inacceptable.
Secondary outcome [1] 372924 0
Cough, visual diagnosis by the surgeon
Timepoint [1] 372924 0
every 5 minutes intraoperatively
Secondary outcome [2] 372925 0
the easy of glottic exposure with scale ( easy, moderate, difficult and inexposable)
Timepoint [2] 372925 0
During the glottic exposure
Secondary outcome [3] 372926 0
the duration of glottic exposure in second with a stopwatch
Timepoint [3] 372926 0
During the glottic exposure
Secondary outcome [4] 372927 0
the duration of the surgery in minute with a stopwatch
Timepoint [4] 372927 0
all surgery
Secondary outcome [5] 372928 0
the recovery time of a spontaneous breathing in minute and second with a stopwatch
Timepoint [5] 372928 0
the recovery phase
Secondary outcome [6] 374197 0
subjective surgical conditions with a scale (excellent-acceptable-to improve-inacceptable)
Timepoint [6] 374197 0
every 5 minutes intraoperatively
Secondary outcome [7] 374198 0
vocal cords movement, visual diagnosis by the surgeon
Timepoint [7] 374198 0
every 5 minutes intraoperatively
Secondary outcome [8] 377299 0
objective surgical conditions. it's the distance between the vocal cords at the anterior and posterior commissures is measured with a calibrator
The calibrator is a palpator for vocal cords who measures 5 mm.
Timepoint [8] 377299 0
every 5 minutes intraoperatively

Eligibility
Key inclusion criteria
Patients for laryngeal micosurgery
Minimum age
18 Years
Maximum age
88 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnant or breast-feeding women, vocal cord paralysis (preoperative fiberoptic screening), patients with renal or hepatic insufficiency and ones with neurological disorders, and any patient with a suspected allergy to the drugs used in the protocol or receiving medications that could interfere with neuromuscular transmission.


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)
Eligible patients will be approached during the anesthesia preoperative visit.
The anesthesia consultant will obtain an informed consent. the treatment received for each patient will be determined on the day of the procedure by minimisation with QMinim software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation
The factors used for stratificatin include gender, age, BMI, Mallampati, mouth opening and extension neck.
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)
Safety/efficacy
Statistical methods / analysis
A minimum of 66 patients was estimated by G*Power 3.1.9.2 software to be required for the trial with an alpha error of 0.05, a power of 0.80 and a one-sided approach, assuming that the primary outcome of changing group from no curare to curare were 20% and 0% respectively. We used a group sequential approach and plan to perform one interim analysis after completion of 50% patients using Pocock boundaries, that is a total of two analyses including the final one, at 0.0294 significance levels (Pocock, 1977 and 1982). Outcomes will be compared using chi square or Fisher exact tests for categorical variables, and Wilcoxon rank sum tests for numerical ones.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21716 0
Belgium
State/province [1] 21716 0
Namur

Funding & Sponsors
Funding source category [1] 302315 0
Hospital
Name [1] 302315 0
CHU UCL Namur
Address [1] 302315 0
CHU UCL Namur
1, Avenue Gaston Therasse
5530 Yvoir
Country [1] 302315 0
Belgium
Primary sponsor type
Individual
Name
Putz Laurie
Address
CHU UCL Namur
1, Avenue Gaston Therasse
5530 Yvoir
Country
Belgium
Secondary sponsor category [1] 302196 0
None
Name [1] 302196 0
Address [1] 302196 0
Country [1] 302196 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302988 0
Comité d'éthique médical hospitalier
Ethics committee address [1] 302988 0
CHU UCL Namur
Avenue Gaston Therasse,1
5530 Yvoir
Ethics committee country [1] 302988 0
Belgium
Date submitted for ethics approval [1] 302988 0
14/06/2016
Approval date [1] 302988 0
06/09/2016
Ethics approval number [1] 302988 0
B039201629150

Summary
Brief summary
The aim of this study is to observe if a deep neuromuscular block improves the surgical conditions during laryngeal microsurgery with high frequencies jet ventilation and if this block facilitates the glottic exposure both in terms of the speed of exposure and the area visualized. The use of the laser during microsurgery requires a total absence of movement in such a context we want to show if there is an interest in deep neuromuscular block.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92086 0
Dr Putz Laurie
Address 92086 0
CHU UCL Namur
avenue Gaston Therasse, 1
5530 Yvoir
Country 92086 0
Belgium
Phone 92086 0
+3281423911
Fax 92086 0
+3281423920
Email 92086 0
laurie.putz@uclouvain.be
Contact person for public queries
Name 92087 0
Dr Putz Laurie
Address 92087 0
CHU UCL Namur
avenue Gaston Therasse, 1
5530 Yv
Country 92087 0
Belgium
Phone 92087 0
+3281423911
Fax 92087 0
+3281423920
Email 92087 0
laurie.putz@uclouvain.be
Contact person for scientific queries
Name 92088 0
Dr Putz Laurie
Address 92088 0
CHU UCL Namur
avenue Gaston Therasse, 1
5530 Yvoir
Country 92088 0
Belgium
Phone 92088 0
+3281423911
Fax 92088 0
+3281423920
Email 92088 0
laurie.putz@uclouvain.be

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It's just data for the study.
What supporting documents are/will be available?
No other documents available
Summary results
No Results