Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation With Moderate vs. Deep Neuromuscular Block
NCT ID: NCT02888067
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
12 participants
INTERVENTIONAL
2017-07-01
2022-07-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Moderate neuromuscular blockade (MNB)
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).
Rocuronium bromide 0.5 mg/kg
Moderate neuromuscular blockade with rocuronium bromide
Sugammadex sodium 2 mg/kg
Reversal with sugammadex sodium
Deep neuromuscular blockade (MNB)
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).
Rocuronium bromide 1.0 mg/kg
Deep neuromuscular blockade with rocuronium bromide
Sugammadex sodium 4 mg/kg
Reversal with sugammadex sodium
Interventions
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Rocuronium bromide 0.5 mg/kg
Moderate neuromuscular blockade with rocuronium bromide
Rocuronium bromide 1.0 mg/kg
Deep neuromuscular blockade with rocuronium bromide
Sugammadex sodium 2 mg/kg
Reversal with sugammadex sodium
Sugammadex sodium 4 mg/kg
Reversal with sugammadex sodium
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Thomas Schricker
OTHER
Responsible Party
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Thomas Schricker
Professor and Chairman,Department of Anesthesia
Principal Investigators
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Thomas Schricker, M.D., PhD.
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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MUHC
Montreal, Quebec, Canada
Countries
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Other Identifiers
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2017-2754
Identifier Type: -
Identifier Source: org_study_id
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