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Sugammadex 2 mg/kg for Neuromuscular Blockade
Study Summary
This trial will study whether sugammadex is better than neostigmine at reversing moderate neuromuscular blockade in infants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 4 trial • 344 Patients • NCT03346057Trial Design
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- You are likely to need a breathing machine (ventilator) after the procedure.You are taking medication that could affect the treatments used in this study.You have a surgical procedure or medical condition that requires monitoring of your neuromuscular transmission.You have a condition that affects your muscles and nerves, which could impact the study's measurements and evaluations.You or someone in your family has had a condition called malignant hyperthermia, which causes high fever during certain medical procedures.You have allergies or suspected allergies to the study treatments, certain medications used for pain or muscle relaxation, or other medications used during anesthesia.
- Group 1: Part A. Sugammadex 2 mg/kg
- Group 2: Part A. Sugammadex 4 mg/kg
- Group 3: Part B. Sugammadex 2 mg/kg
- Group 4: Part B. Sugammadex 4 mg/kg
- Group 5: Part B. Neostigmine
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the eligibility criteria for enrolment in this trial?
"This medical trial is enrolling 126 infants between the day of birth and two years old who require neuromuscular blockade for a non-emergency surgical procedure or intubation. Prospective participants must meet all these requirements: they have to be either male or female, no older than 2 years, and their situation has to permit the use of monitoring techniques during neuromuscular transmission."
Does the criteria for this study allow individuals over 25 years of age to participate?
"This clinical trial requires that participants are between infant age and 2 years old. Separately, there are 16 studies for those below 18 and 43 for the elderly demographic (over 65)."
What potential adverse effects should be anticipated when administering Sugammadex 2 mg/kg to patients?
"Sugammadex 2 mg/kg is approved as a Phase 4 medication and thus has been assigned the maximum safety rating of 3."
Is this experiment still accepting participants?
"According to the listing on clinicaltrials.gov, this medical trial is presently searching for patients to take part in its research. It was inaugurated back on July 23rd 2019 and underwent a subsequent update two years later, on September 17th 2022."
What is the typical application of Sugammadex 2 mg/kg?
"Sugammadex 2 mg/kg is most frequently prescribed for reflex and trigeminocardiac ailments. It has also displayed efficacy in treating bodily secretions, denture retention, and ureteric colic related symptoms."
Have any past experiments tested the efficacy of Sugammadex 2 mg/kg?
"Sugammadex 2 mg/kg has been a subject of research since 2009, when South Texas Veterans Health Care System first began trials. In total, 342 studies have already concluded and 43 are ongoing - many in Houston, TX."
To what extent is this experiment being participated in by individuals?
"Affirmative. Clinicaltrials.gov indicates that this research is recruiting patients, having been initially posted on July 23rd 2019 and most recently edited September 17th 2022. 126 participants are sought from 3 different sites for the study."
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