Neuromuscular Blockade reversal MedDRA version: 21.1 Level: PT Classification code 10057286 Term: Neuromuscular blockade reversal System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 *Nonsteroidal NMBAs such as succinylcholine or benzylisoquinolinium compound (eg, cisatracurium). (Except in the circumstance that renewed muscle relaxation is needed after administration of study treatment, in which case a non-steroidal NMBA should be administered) 10. Has been previously treated with sugammadex or has participated in a sugammadex clinical trial within 30 days of signing the informed consent form of this current 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To describe the pharmacokinetic parameters of sugammadex when used for reversal of moderate neuromuscular blockade (NMB) or deep NMB (Part A). 2. To evaluate the time to neuromuscular recovery of sugammadex in comparison to neostigmine for the reversal of moderate NMB (Part B). 3. To evaluate the safety and tolerability of sugammadex (data will be pooled across Part A and Part B of the study) ;Secondary Objective: 1. To evaluate the time to extubation of sugammadex in comparison to neostigmine for the reversal of moderate neuromuscular blockade (Part B).;Primary end point(s): 1.Part A. Area Under the Plasma Concentration Time Curve (AUC) for Sugammadex 2.Part A. Plasma Clearance (CL) of Sugammadex 3.Part A. Apparent Volume of Distribution (Vz) for Sugammadex 4.Part A. Apparent Volume of Distribution at Steady State (Vss) for Sugammadex 5.Part A. Maximum Plasma Concentration (Cmax) of Sugammadex 6.Part A. Half-Life (t1/2) of Sugammadex in Plasma 7.Part B. Time to Neuromuscular Recovery 8.Parts A and B. Adverse Event (AEs) ;Timepoint(s) of evaluation of this end point: 1.Baseline and 2, 15, 30, 60, 300, and 600 to 720 minutes post-dose 2.Baseline and 2, 15, 30, 60, 300, and 600 to 720 minutes post-dose 3.Baseline and 2, 15, 30, 60, 300, and 600 to 720 minutes post-dose 4.Baseline and 2, 15, 30, 60, 300, and 600 to 720 minutes post-dose 5.Baseline and 2, 15, 30, 60, 300, and 600 to 720 minutes post-dose 6.Baseline and 2, 15, 30, 60, 300, and 600 to 720 minutes post-dose 7. Within Day 1 8. Up to 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Part B. Time to Extubation;Timepoint(s) of evaluation of this end point: 1. Within Day 1 | — |
Countries
Australia, Belgium, Brazil, Denmark, Finland, France, Hungary, Malaysia, Netherlands, United States
Contacts
Public ContactYuki Mukai
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed