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

High-Frequency Jet Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02888067
• Other study ID #: 2017-2754
• Status: Terminated
• Phase: Phase 1
• Start date: July 1, 2017
• Est. completion date: July 20, 2022

Study information

• Verified date: October 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 20, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• High-Frequency Jet Ventilation
• Vocal Cord Resection

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	MUHC	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Schricker	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Five-point surgical rating scale (SRS)	Surgical conditions during surgery will be assessed by the surgeon using a five-point surgical rating scale at 10 minutes intervals	during surgery, an average period of 50 minutes
Secondary	Drug dosages	Drugs and dosages used during the study	Through study completion, an average of 4 hours
Secondary	Time to extubation	Time from reversal to optimal extubation conditions (TOF ratio <0.9)	During the stay in the operation room, an average of 60 minutes
Secondary	Heart rate		During the stay in the operation and recovery room, an average of 4 hours
Secondary	Arterial blood pressure		During the stay in the operation and recovery room, an average of 4 hours
Secondary	Oxygen saturation		During the stay in the operation and recovery room, an average of 4 hours
Secondary	Respiratory rate		During the stay in the operation and recovery room, an average of 4 hours
Secondary	Body temperature		During the stay in the operation and recovery room, an average of 4 hours
Secondary	Duration of surgery		During the stay in the operation room, an average of 50 minutes
Secondary	Duration of post-anesthesia care unit (PACU) stay	Time spent in the PACU	During the stay in the recovery room, an average of 3 hours
Secondary	Pain score	On an 11-point numerical rating scale from 0 = no pain, to 10 = most severe pain imaginable at PACU	During the stay in the operation and recovery room, an average of 4 hours
Secondary	Occurence of nausea/vomiting		During the stay in the operation and recovery room, an average of 4 hours
Secondary	Sedation	On a five-point scale ranging from 0 = normal alertness to 5 = not aroused by a painful stimulus at PACU	During the stay in the operation and recovery room, an average of 4 hours