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Slow recruitment
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate neuromuscular blockade (MNB) | Active Comparator | 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). |
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| Deep neuromuscular blockade (MNB) | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium bromide 0.5 mg/kg | Drug | Moderate neuromuscular blockade with rocuronium bromide |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Schricker, M.D., PhD. | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUHC | Montreal | Quebec | H4A3J1 | Canada |
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| Rocuronium bromide 1.0 mg/kg | Drug | Deep neuromuscular blockade with rocuronium bromide |
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| Sugammadex sodium 2 mg/kg | Drug | Reversal with sugammadex sodium |
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| Sugammadex sodium 4 mg/kg | Drug | Reversal with sugammadex sodium |
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| 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 |
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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