Reversal of neuromuscular blockade (NMB) MedDRA version: 21.1 Level: LLT Classification code 10018061 Term: General anesthesia System Organ Class: 100000004865
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must be categorized as ASA Physical Status Class 1, 2, or 3, as determined by the investigator 2. Have a planned non-emergent surgical procedure or clinical situation (eg, intubation) that requires moderate or deep NMB with either rocuronium or vecuronium 3. Have a planned surgical procedure or clinical situation that would allow objective neuromuscular monitoring techniques to be applied with access to the arm for neuromuscular transmission monitoring 4. Age between 2 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has any clinically significant condition or situation (eg, anatomical malformation that complicates intubation) other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial 2. Has a neuromuscular disorder that may affect NMB and/or trial assessments 3. 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) 4. Has or is suspected of having a family or personal history of malignant hyperthermia 5. 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 6. 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 7. A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment. If the urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive 8. Use of medication expected to interfere with study treatments given in this trial, as per prescribing information 9. Has been previously treated with sugammadex or has participated in a sugammadex clinical trial 10. 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 11. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To describe the pharmacokinetic parameters of sugammadex when used for reversal of moderate NMB or deep NMB (Part A) 2. To evaluate safety and tolerability of sugammadex (data will be pooled across Part A and Part B of the study) 3. To evaluate the efficacy of sugammadex in comparison to neostigmine for the reversal of moderate NMB (Part B);Secondary Objective: To evaluate the efficacy of sugammadex in comparison to neostigmine for the reversal of moderate NMB (Part B);Primary end point(s): 1. Part A only- Pharmacokinetic: Area under the plasma concentration-time curve (AUC), clearance (CL), volume of distribution (Vz), maximum plasma concentration (Cmax), and half-life (t1/2) 2. Part A and Part B- Safety: Adverse event (AE) reporting, laboratory and vital sign assessments. Events of clinical interest: clinically relevant bradycardia, hypersensitivity and anaphylaxis. 3. Part B only - Efficacy: The time to recovery to a train-of-four (TOF) ratio of =0.9;Timepoint(s) of evaluation of this end point: 1. PK samples collected at 2, 15, 30, 60 mi., 5 and 10 hours post-administration of study drug 2. AEs reported throughout participation in the study (~ 28 days). Safety laboratory assessments at Day1 (peri-anesthetic period) and Day 1 to 2 (post-treatment). Vital signs assessments on Day 1: Prior to administration of NMBA; Prior to administration of study treatment; and 2, 5, 10 and 30 min. after study treatment. 3. Neuromuscular monitoring will be performed using a TOF-Watch SX®. After induction of anesthesia, neuromuscular monitoring will start before the administration of neuromuscular blocking agent. Neuromuscular monitoring should remain ongoing until the participant reaches the endpoint of TOF =0.9, or for at least 30 min. following administration of a single dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The time to recovery to a TOF ratio of =0.8 2. The time to recovery to a TOF ratio of =0.7;Timepoint(s) of evaluation of this end point: 1. Neuromuscular monitoring will be performed using a TOF-Watch SX®. After induction of anesthesia, neuromuscular monitoring will start before the administration of neuromuscular blocking agent. Neuromuscular monitoring should remain ongoing until the participant reaches the endpoint of TOF ratio =0.8, or for at least 30 minutes following administration of a single dose of study drug. 2. Neuromuscular monitoring will be performed using a TOF-Watch SX®. After induction of anesthesia, neuromuscular monitoring will start before the administration of neuromuscular blocking agent. Neuromuscular monitoring should remain ongoing until the participant reaches the endpoint of TOF ratio =0.7, or for at least 30 minutes following administration of a single dose of study drug. | — |
Countries
Austria, Belgium, Denmark, Finland, Germany, Spain, Turkey, United States
Contacts
Public ContactGlobal Clinical Trial Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck
Outcome results
None listed