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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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the stay in the operation room, an average of 60 minutes

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

3,887 Previous Clinical Trials

5,054,602 Total Patients Enrolled

Thomas Schricker, M.D., PhD.Principal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What benefits does Moderate neuromuscular blockade (MNB) typically provide?

"Through Moderate neuromuscular blockade (MNB), intubation, muscular fasciculation and curarization therapy can be therapeutically induced."

Answered by AI

Is participation still open for this research endeavor?

"Affirmative. The information on clinicaltrials.gov suggests that this research is actively recruiting participants and was initially posted in July 2017, with its most recent update being made in April 2022. 30 people are needed to be recruited from one location for the trial's completion."

Answered by AI

Does Moderate neuromuscular blockade (MNB) pose a health risk to individuals?

"Our team at Power assigned a score of 1 to moderate neuromuscular blockade's safety because there is limited evidence suggesting its efficacy and safety."

Answered by AI

Does this trial offer any novel approaches to treating the condition?

"Since Medtronic-MITG sponsored the original Moderate Neuromuscular Blockade (MNB) trial in 2009, there has been a surge of clinical studies, leading to its N/A drug approval. Currently, 24 MNB trials are active across 39 cities and 22 nations."

Answered by AI

How many individuals are being monitored in this medical experiment?

"Affirmative. The information hosted on clinicaltrials.gov states that this investigation, which was uploaded to the website on July 1st 2017, is actively recruiting participants. 30 patients are required from a single medical centre ."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Thomas Schricker 2017. "Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation With Moderate vs. Deep Neuromuscular Block". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02888067.