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

NCT02888067 | Terminated Phase 1

• 1 other identifier: 2017-2754
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Frequency Jet Ventilation; Vocal Cord Resection

Keywords

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Drug dosages

  Through study completion, an average of 4 hours

• Time to extubation

  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

Study Arms (2)

Moderate neuromuscular blockade (MNB)

ACTIVE COMPARATOR

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; Drug: Sugammadex sodium 2 mg/kg

Deep neuromuscular blockade (MNB)

ACTIVE COMPARATOR

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; Drug: Sugammadex sodium 4 mg/kg

Interventions

Rocuronium bromide 0.5 mg/kg DRUG

Moderate neuromuscular blockade with rocuronium bromide

Also known as: Zemuron®

Moderate neuromuscular blockade (MNB)

Rocuronium bromide 1.0 mg/kg DRUG

Deep neuromuscular blockade with rocuronium bromide

Also known as: Zemuron®

Deep neuromuscular blockade (MNB)

Sugammadex sodium 2 mg/kg DRUG

Reversal with sugammadex sodium

Also known as: Bridion™

Moderate neuromuscular blockade (MNB)

Sugammadex sodium 4 mg/kg DRUG

Reversal with sugammadex sodium

Also known as: Bridion™

Deep neuromuscular blockade (MNB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective vocal cord resection with an expected length of the procedure longer than 20 minutes and requiring jet ventilation

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thomas Schricker: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

MUHC

Montreal, Quebec, H4A3J1, Canada

Location

MeSH Terms

Interventions

Rocuronium; Sugammadex

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Thomas Schricker, M.D., PhD.

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chairman,Department of Anesthesia

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: September 2, 2016
• Study Start: July 1, 2017
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)