Clinical trial NCT02888067: Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation With Moderate vs. Deep Neuromuscular Block
Official title: Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation in Patients With Moderate vs. Deep Neuromuscular Block
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: High-Frequency Jet Ventilation
Vocal Cord Resection
Keywords: Neuromuscular Blockade
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-09-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Five-point surgical rating scale (SRS)
timeFrame: during surgery, an average period of 50 minutes
Secondary outcomes:
measure: Drug dosages
timeFrame: Through study completion, an average of 4 hours
measure: Time to extubation
timeFrame: During the stay in the operation room, an average of 60 minutes
measure: Heart rate
timeFrame: During the stay in the operation and recovery room, an average of 4 hours
measure: Arterial blood pressure
timeFrame: During the stay in the operation and recovery room, an average of 4 hours
measure: Oxygen saturation
timeFrame: During the stay in the operation and recovery room, an average of 4 hours
measure: Respiratory rate
timeFrame: During the stay in the operation and recovery room, an average of 4 hours
measure: Body temperature
timeFrame: During the stay in the operation and recovery room, an average of 4 hours
measure: Duration of surgery
timeFrame: During the stay in the operation room, an average of 50 minutes
measure: Duration of post-anesthesia care unit (PACU) stay
timeFrame: During the stay in the recovery room, an average of 3 hours
measure: Pain score
timeFrame: During the stay in the operation and recovery room, an average of 4 hours
measure: Occurence of nausea/vomiting
timeFrame: During the stay in the operation and recovery room, an average of 4 hours
measure: Sedation
timeFrame: During the stay in the operation and recovery room, an average of 4 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MUHC
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Thomas Schricker, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References: