Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation With Moderate vs. Deep Neuromuscular Block
- Conditions
- High-Frequency Jet VentilationVocal Cord Resection
- Interventions
- Registration Number
- NCT02888067
- Lead Sponsor
- Thomas Schricker
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
- Elective vocal cord resection with an expected length of the procedure longer than 20 minutes and requiring jet ventilation
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate neuromuscular blockade (MNB) Rocuronium bromide 0.5 mg/kg 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). Deep neuromuscular blockade (MNB) Rocuronium bromide 1.0 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). Moderate neuromuscular blockade (MNB) Sugammadex sodium 2 mg/kg 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). Deep neuromuscular blockade (MNB) Sugammadex sodium 4 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).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Drug dosages Through study completion, an average of 4 hours Drugs and dosages used during the study
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 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 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
Trial Locations
- Locations (1)
MUHC
🇨🇦Montreal, Quebec, Canada