PK, SAFETY, AND EFFICACY OF SUGAMMADEX IN CHILDREN AGED BIRTH TO <2 YEARS
- Conditions
- -G70G70
- Registration Number
- PER-065-20
- Lead Sponsor
- Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 0
1. Is categorized as ASA Physical Status Class 1, 2, or 3 as determined by the investigator.
2. Has a planned non-emergent surgical procedure or clinical situation (eg, intubation) that requires moderate or deep NMB with either rocuronium or vecuronium.
3. Has a surgical procedure or clinical situation that would allow neuromuscular monitoring techniques to be applied for neuromuscular transmission monitoring.
4. Is male or female, between birth and <2 years of age at Visit 2.
5. The legally acceptable representative for the study participant provides written informed consent/assent for the trial.
Please refer to the protocol for more information.
1. Is a preterm infant or neonate <36 weeks gestational age at birth.
2. Has any clinically significant condition or situation (eg, anatomical malformation that complicates intubation) other than the condition requiring the use of NMBA that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
3. Has a neuromuscular disorder that may affect NMB and/or trial assessments.
4. Is dialysis-dependent or has (or is suspected of having) severe renal insufficiency (defined as estimated glomerular filtration rate [eGFR] <30 ml/min; using revised Schwartz estimate as method of calculation).
5. Has or is suspected of having a family or personal history of malignant hyperthermia.
6. Has or is suspected of having an allergy to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.
7. Is expected to require mechanical ventilation after the procedure.
8. Has received or is planned to receive toremifene and/or fusidic acid via IV Administration within 24 hours before or within 24 hours after administration of study treatment.
9. Use of medication expected to interfere with study treatments given in this trial, as per prescribing information. Rocuronium or vecuronium are concomitant medications to be used per label as adjunct to general anesthesia. Besides rocuronium or vecuronium, a participant must not be administered any other NMBA during the trial, including: Other steroidal NMBAs, such as pancuronium or Nonsteroidal NMBAs such as succinylcholine or benzylisoquinolinium compound.
10. Has been previously treated with sugammadex or has participated in a sugammadex clinical trial.
11. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent/assent for this current trial.
12. Is or has an immediate family member (eg, parent/legal guardian, or sibling) who is investigational site or Sponsor staff directly involved with this study.
Please refer to the protocol for more information.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Cox Proportional Hazards Model<br><br>Measure:Time to Extubation<br>Timepoints:Time to extubation and time to neuromuscular recovery (both censored at 120 minutes)<br>;<br>Outcome name:Stratified Log-rank Test, Kaplan Meier Curves<br><br>Measure:Time to Extubation<br>Timepoints:Interval from administration of reversal agent to removal of the endotracheal tube<br>;<br>Outcome name:Miettinen and Nurminen method<br>Measure:Proportion of adverse events (AE) and Discontinuation of study intervention due to AEs<br>Timepoints:From the time of intervention allocation/randomization through 14 days following cessation of treatment<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Cox Proportional Hazards Model<br><br>Measure:Time to Neuromuscular Recovery<br><br>Timepoints:Time to extubation and time to neuromuscular recovery (both censored at 120 minutes)<br>;<br>Outcome name:Stratified Log-rank Test, Kaplan Meier Curves<br><br>Measure:Time to Neuromuscular Recovery<br><br>Timepoints:Interval from administration of reversal agent to time to neuromuscular readiness for extubation<br>