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High-Frequency Jet VentilationPhase 1NCT02888067

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

A Phase 1 study testing Rocuronium bromide 0.5 mg/kg, Rocuronium bromide 1.0 mg/kg and Sugammadex sodium 2 mg/kg in people with High-Frequency Jet Ventilation and Vocal Cord Resection, run by Thomas Schricker at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rocuronium bromide 0.5 mg/kg, Rocuronium bromide 1.0 mg/kg and Sugammadex sodium 2 mg/kg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
1 Jul 2017to 20 Jul 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Canada1 site

  • MUHC

    Montreal, Quebec, H4A3J1

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Rocuronium bromide 0.5 mg/kg, Rocuronium bromide 1.0 mg/kg, Sugammadex sodium 2 mg/kg, Sugammadex sodium 4 mg/kg
Keywords
Neuromuscular Blockade

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rocuronium bromide 0.5 mg/kgDrug

    Also called Zemuron®

    Moderate neuromuscular blockade with rocuronium bromide

  • Rocuronium bromide 1.0 mg/kgDrug

    Also called Zemuron®

    Deep neuromuscular blockade with rocuronium bromide

  • Sugammadex sodium 2 mg/kgDrug

    Also called Bridion™

    Reversal with sugammadex sodium

  • Sugammadex sodium 4 mg/kgDrug

    Also called Bridion™

    Reversal with sugammadex sodium

Study groups in NCT02888067
Study groupRoleWhat they receive
Moderate neuromuscular blockade (MNB)Active comparatorThe 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).
Receives: Drug: Rocuronium bromide 0.5 mg/kg; Drug: Sugammadex sodium 2 mg/kg
Deep neuromuscular blockade (MNB)Active comparatorThe 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).
Receives: Drug: Rocuronium bromide 1.0 mg/kg; Drug: Sugammadex sodium 4 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: during surgery, an average period of 50 minutes

Secondary outcomes (12)

  1. Drug dosages

    Drugs and dosages used during the study

    Measured: Through study completion, an average of 4 hours

  2. Time to extubation

    Time from reversal to optimal extubation conditions (TOF ratio <0.9)

    Measured: During the stay in the operation room, an average of 60 minutes

  3. Heart rate

    Measured: During the stay in the operation and recovery room, an average of 4 hours

  4. Arterial blood pressure

    Measured: During the stay in the operation and recovery room, an average of 4 hours

  5. Oxygen saturation

    Measured: During the stay in the operation and recovery room, an average of 4 hours

  6. Respiratory rate

    Measured: During the stay in the operation and recovery room, an average of 4 hours

  7. Body temperature

    Measured: During the stay in the operation and recovery room, an average of 4 hours

  8. Duration of surgery

    Measured: During the stay in the operation room, an average of 50 minutes

  9. Duration of post-anesthesia care unit (PACU) stay

    Time spent in the PACU

    Measured: During the stay in the recovery room, an average of 3 hours

  10. Pain score

    On an 11-point numerical rating scale from 0 = no pain, to 10 = most severe pain imaginable at PACU

    Measured: During the stay in the operation and recovery room, an average of 4 hours

  11. Occurence of nausea/vomiting

    Measured: During the stay in the operation and recovery room, an average of 4 hours

  12. Sedation

    On a five-point scale ranging from 0 = normal alertness to 5 = not aroused by a painful stimulus at PACU

    Measured: During the stay in the operation and recovery room, an average of 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2016 (estimated)
  2. Study start1 Jul 2017
  3. Primary completion20 Jul 2022
  4. Study completion20 Jul 2022

Why it stopped: Slow recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02888067
Sponsor's protocol ID
2017-2754
Status last verified
Oct 2023
First submitted
12 Aug 2016
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rocuronium bromide 0.5 mg/kg, Rocuronium bromide 1.0 mg/kg and Sugammadex sodium 2 mg/kg in people with High-Frequency Jet Ventilation and Vocal Cord Resection, run by Thomas Schricker at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Five-point surgical rating scale (SRS) (time frame: during surgery, an average period of 50 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02888067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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