Skip to content

Laryngeal microsurgery under deep neuromuscular block

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001700123
Enrollment
33
Registered
2019-12-03
Start date
2016-11-08
Completion date
2018-01-05
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 neuromus

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.

Sponsors

Putz Laurie
Lead SponsorIndividual

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 88 Years
Healthy volunteers
No

Inclusion criteria

Patients for laryngeal micosurgery

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026