Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation With Moderate vs. Deep Neuromuscular Block

Study Overview
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Brief Summary
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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
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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.

Official Title
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Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation in Patients With Moderate vs. Deep Neuromuscular Block

Conditions
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High-Frequency Jet Ventilation, Vocal Cord Resection

Intervention / Treatment
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* Drug: Rocuronium bromide 0.5 mg/kg
* Drug: Rocuronium bromide 1.0 mg/kg
* Drug: Sugammadex sodium 2 mg/kg
* Drug: Sugammadex sodium 4 mg/kg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moderate neuromuscular blockade (MNB)<br>The goal is to realize a moderate NMB (TOF 1-2 twitches). NMB will be induced with a bolus dose of rocuronium (Non-depolarizing Skeletal Neuromuscular Blocking Agent). If the target TOF values was not reached bolus doses of rocuronium (5 mg) will be given to achieve the target. This represents the standard care in our institution for this type of surgery. At the end of surgery, neuromuscular blockade in all patients will be reversed by sugammadex: patients in the moderate neuromuscular blockade group will receive sugammadex (Selective Relaxant Binding Agent). | Drug: Rocuronium bromide 0.5 mg/kg<br>* Moderate neuromuscular blockade with rocuronium bromide<br>* Other names: Zemuron®;Drug: Sugammadex sodium 2 mg/kg<br>* Reversal with sugammadex sodium<br>* Other names: Bridion™;|
| Active Comparator: Deep neuromuscular blockade (MNB)<br>The goal is to realize a deep MNB (TOF zero twitches). NMB will be induced with a bolus dose of rocuronium (Non-depolarizing Skeletal Neuromuscular Blocking Agent). If the target TOF values was not reached bolus doses of rocuronium (5 mg) will be given to achieve the target. At the end of surgery, neuromuscular blockade in all patients will be reversed by sugammadex: patients in the deep neuromuscular blockade group will receive sugammadex (Selective Relaxant Binding Agent). | Drug: Rocuronium bromide 1.0 mg/kg<br>* Deep neuromuscular blockade with rocuronium bromide<br>* Other names: Zemuron®;Drug: Sugammadex sodium 4 mg/kg<br>* Reversal with sugammadex sodium<br>* Other names: Bridion™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five-point surgical rating scale (SRS) | Surgical conditions during surgery will be assessed by the surgeon using a five-point surgical rating scale at 10 minutes intervals | during surgery, an average period of 50 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug dosages | Drugs and dosages used during the study | Through study completion, an average of 4 hours | 
| Time to extubation | Time from reversal to optimal extubation conditions (TOF ratio <0.9) | During the stay in the operation room, an average of 60 minutes | 
| 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 | 
| Body temperature |  | During the stay in the operation and recovery room, an average of 4 hours | 
| Duration of surgery |  | During the stay in the operation room, an average of 50 minutes | 
| Duration of post-anesthesia care unit (PACU) stay | Time spent in the PACU | During the stay in the recovery room, an average of 3 hours | 
| Pain score | On an 11-point numerical rating scale from 0 = no pain, to 10 = most severe pain imaginable at PACU | During the stay in the operation and recovery room, an average of 4 hours | 
| Occurence of nausea/vomiting |  | During the stay in the operation and recovery room, an average of 4 hours | 
| Sedation | On a five-point scale ranging from 0 = normal alertness to 5 = not aroused by a painful stimulus at PACU | During the stay in the operation and recovery room, an average of 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromuscular Blockade