Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation With Moderate vs. Deep Neuromuscular Block

Thomas Schricker

Status and phase: Terminated; Phase 1

Conditions: High-Frequency Jet Ventilation; Vocal Cord Resection

Treatments: Drug: Sugammadex sodium 4 mg/kg; Drug: Sugammadex sodium 2 mg/kg; Drug: Rocuronium bromide 0.5 mg/kg; Drug: Rocuronium bromide 1.0 mg/kg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02888067

2017-2754

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 2 patient groups

Moderate neuromuscular blockade (MNB)

Active Comparator group

Description:

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).

Treatment:

Drug: Sugammadex sodium 2 mg/kg

Drug: Rocuronium bromide 0.5 mg/kg

Deep neuromuscular blockade (MNB)

Active Comparator group

Description:

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).

Treatment:

Drug: Rocuronium bromide 1.0 mg/kg

Drug: Sugammadex sodium 4 mg/kg