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

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.

Study Overview

• Status: Terminated
• Conditions: High-Frequency Jet Ventilation; Vocal Cord Resection
• Intervention / Treatment: Drug: Rocuronium bromide 0.5 mg/kg; Drug: Sugammadex sodium 2 mg/kg; Drug: Rocuronium bromide 1.0 mg/kg; Drug: Sugammadex sodium 4 mg/kg

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Thomas Schricker, M.D., PhD.; Phone Number: 36423 5149341934; Email: thomas.schricker@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A3J1
      • MUHC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Drug: Rocuronium bromide 0.5 mg/kg; Moderate neuromuscular blockade with rocuronium bromide; Other Names: Zemuron®; Drug: Sugammadex sodium 2 mg/kg; Reversal with sugammadex sodium; Other Names: Bridion™
Active Comparator: 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).	Drug: Rocuronium bromide 1.0 mg/kg; Deep neuromuscular blockade with rocuronium bromide; Other Names: Zemuron®; Drug: Sugammadex sodium 4 mg/kg; Reversal with sugammadex sodium; Other Names: Bridion™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug dosages	Drugs and dosages used during the study	Through study completion, an average of 4 hours
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
Heart rate		During the stay in the operation and recovery room, an average of 4 hours
Arterial blood pressure		During the stay in the operation and recovery room, an average of 4 hours
Oxygen saturation		During the stay in the operation and recovery room, an average of 4 hours
Respiratory rate		During the stay in the operation and recovery room, an average of 4 hours
Body temperature		During the stay in the operation and recovery room, an average of 4 hours
Duration of surgery		During the stay in the operation room, an average of 50 minutes
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
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
Occurence of nausea/vomiting		During the stay in the operation and recovery room, an average of 4 hours
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

Collaborators and Investigators

• Sponsor: Thomas Schricker
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Thomas Schricker, M.D., PhD., McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: August 12, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimated): September 2, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Neuromuscular Blockade
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anticonvulsants; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Bromides; Rocuronium
• Other Study ID Numbers: 2017-2754

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No