A Phase 1 interventional study of Rocuronium bromide 0.5 mg/kg and Rocuronium bromide 1.0 mg/kg in High-Frequency Jet Ventilation and Vocal Cord Resection, sponsored by Thomas Schricker. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Thomas Schricker · Phase 1, Interventional, and Other
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.
This is the only study on the registry with Thomas Schricker as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Sugammadex sodium 2 mg/kg
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 · Drug: Sugammadex sodium 4 mg/kg
Moderate neuromuscular blockade with rocuronium bromide
Also known as: Zemuron®
Deep neuromuscular blockade with rocuronium bromide
Also known as: Zemuron®
Reversal with sugammadex sodium
Also known as: Bridion™
Reversal with sugammadex sodium
Also known as: Bridion™
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
Time frame: during surgery, an average period of 50 minutes
Drug dosages
Drugs and dosages used during the study
Time frame: Through study completion, an average of 4 hours
Time to extubation
Time from reversal to optimal extubation conditions (TOF ratio \<0.9)
Time frame: During the stay in the operation room, an average of 60 minutes
Heart rate
Time frame: During the stay in the operation and recovery room, an average of 4 hours
Arterial blood pressure
Time frame: During the stay in the operation and recovery room, an average of 4 hours
Oxygen saturation
Time frame: During the stay in the operation and recovery room, an average of 4 hours
Respiratory rate
Time frame: During the stay in the operation and recovery room, an average of 4 hours
Body temperature
Time frame: During the stay in the operation and recovery room, an average of 4 hours
Duration of surgery
Time frame: 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
Time frame: 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
Time frame: During the stay in the operation and recovery room, an average of 4 hours
Occurence of nausea/vomiting
Time frame: 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
Time frame: During the stay in the operation and recovery room, an average of 4 hours
Plan to share: No
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This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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