NCT02888067

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Thomas Schricker · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High-Frequency Jet Ventilation
• Vocal Cord Resection

Interventions

Type	Name	Description
DRUG	Rocuronium bromide 0.5 mg/kg	Moderate neuromuscular blockade with rocuronium bromide
DRUG	Rocuronium bromide 1.0 mg/kg	Deep neuromuscular blockade with rocuronium bromide
DRUG	Sugammadex sodium 2 mg/kg	Reversal with sugammadex sodium
DRUG	Sugammadex sodium 4 mg/kg	Reversal with sugammadex sodium

Timeline

• Start date: 2017-07-01
• Primary completion: 2022-07-20
• Completion: 2022-07-20
• First posted: 2016-09-02
• Last updated: 2023-10-23

Locations

1 site across 1 country: Canada