High-Frequency Jet Ventilation, Vocal Cord Resection
Conditions
Keywords
Neuromuscular Blockade
Brief summary
The purpose of this study is to determine whether deep neuromuscular blockade provides better surgical conditions than moderate neuromuscular blockade in patients undergoing vocal cord resections requiring jet ventilation.
Detailed description
To optimize anatomical exposure and to minimize direct manipulation of local lesions endotracheal intubation often is avoided in patients undergoing vocal cord surgery. Instead intermittent so called jet ventilation is carried out by using the Hunsaker Mon-jet tube. The safe conduct of these procedures requires full muscle paralysis. In clinical practice, however, deep neuromuscular blockade (NMB) usually cannot be established for this relatively short surgery (\<1h) because of an increased risk of prolonged NMB and postoperative ventilation. The novel neuromuscular blockade reversal agent sugammadex may prove particularly useful in this patient population because it allows fast and reliable reversal of even deep NMB. Deeper muscle paralysis during vocal cord surgery may be associated with better surgical conditions. The purpose of this study is to determine whether deep neuromuscular blockade provides better surgical conditions than moderate neuromuscular blockade in patients undergoing vocal cord resections requiring jet ventilation.
Interventions
DRUGRocuronium bromide 0.5 mg/kg
Moderate neuromuscular blockade with rocuronium bromide
DRUGRocuronium bromide 1.0 mg/kg
Deep neuromuscular blockade with rocuronium bromide
DRUGSugammadex sodium 2 mg/kg
Reversal with sugammadex sodium
DRUGSugammadex sodium 4 mg/kg
Reversal with sugammadex sodium
Sponsors
Merck Sharp & Dohme LLC
Thomas Schricker
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective vocal cord resection with an expected length of the procedure longer than 20 minutes and requiring jet ventilation
Exclusion criteria
* Patients younger than 18 years old * Patients unable to give written informed consent * Patients with known or suspected neuromuscular disease * Patients with allergies to medications to be used during anesthesia * Patients with a (family) history of malignant hyperthermia * Patients with renal insufficiency (serum creatinine \>2 times normal or a glomerular filtration rate \<60 ml/h)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Five-point surgical rating scale (SRS) | during surgery, an average period of 50 minutes | Surgical conditions during surgery will be assessed by the surgeon using a five-point surgical rating scale at 10 minutes intervals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to extubation | During the stay in the operation room, an average of 60 minutes | Time from reversal to optimal extubation conditions (TOF ratio \<0.9) |
| Heart rate | During the stay in the operation and recovery room, an average of 4 hours | — |
| Arterial blood pressure | During the stay in the operation and recovery room, an average of 4 hours | — |
| Oxygen saturation | During the stay in the operation and recovery room, an average of 4 hours | — |
| Respiratory rate | During the stay in the operation and recovery room, an average of 4 hours | — |
| Drug dosages | Through study completion, an average of 4 hours | Drugs and dosages used during the study |
| Duration of surgery | During the stay in the operation room, an average of 50 minutes | — |
| Duration of post-anesthesia care unit (PACU) stay | During the stay in the recovery room, an average of 3 hours | Time spent in the PACU |
| Pain score | During the stay in the operation and recovery room, an average of 4 hours | On an 11-point numerical rating scale from 0 = no pain, to 10 = most severe pain imaginable at PACU |
| Occurence of nausea/vomiting | During the stay in the operation and recovery room, an average of 4 hours | — |
| Sedation | During the stay in the operation and recovery room, an average of 4 hours | On a five-point scale ranging from 0 = normal alertness to 5 = not aroused by a painful stimulus at PACU |
| Body temperature | During the stay in the operation and recovery room, an average of 4 hours | — |
Countries
Canada
Outcome results
None listed