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Deep neuromuscular blockade (MNB) for Vocal Cord Resection

Phase 1
Waitlist Available
Led By Thomas Schricker, M.D., PhD.
Research Sponsored by Thomas Schricker
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the stay in the operation room, an average of 60 minutes
Awards & highlights

Summary

This trial will help researchers understand if deep neuromuscular blockade provides better surgical conditions for patients who need jet ventilation during vocal cord resection.

Eligible Conditions
  • Vocal Cord Resection
  • High Frequency Jet Ventilation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the stay in the operation room, an average of 60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the stay in the operation room, an average of 60 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Five-point surgical rating scale (SRS)
Secondary outcome measures
Arterial blood pressure
Body temperature
Drug dosages
+9 more

Trial Design

2Treatment groups
Active Control
Group I: Deep neuromuscular blockade (MNB)Active Control2 Interventions
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).
Group II: Moderate neuromuscular blockade (MNB)Active Control2 Interventions
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).

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Who is running the clinical trial?

Thomas SchrickerLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,251 Total Patients Enrolled
Thomas Schricker, M.D., PhD.Principal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
~1 spots leftby Jul 2025
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