Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)

Study Overview
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Brief Summary
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This study will compare the incidence of residual neuromuscular blockade in participants who undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).

Official Title
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Effect of Sugammadex Compared With Usual Care for Reversal of Neuromuscular Blockade Induced by Rocuronium on Incidence of Residual Blockade at PACU Entry

Conditions
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Surgical Procedures, Elective

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine
* Drug: Glycopyrrolate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) Class 1 or 2 or 3 Scheduled to undergo an elective abdominal surgical procedure under general anesthesia; and: expected to undergo neuromuscular relaxation with rocuronium for endotracheal intubation; and expected to require at least one maintenance dose of rocuronium; and expected to require active reversal of neuromuscular blockade; and expected to require clinical or subjective neuromuscular monitoring only; and expected to recover in the PACU Arm that is accessible for measuring the TOF ratio in the PACU Sexually active female patient of child-bearing potential must agree to use a medically accepted method of contraception through seven days after receiving protocol-specified medication. Exclusion Criteria: Anatomical malformations that may lead to difficult intubation Neuromuscular disorder(s) that may affect neuromuscular blockade and/or trial assessments Dialysis-dependent or has or is suspected of having severe renal insufficiency Significant hepatic dysfunction Family history of malignant hyperthermia Cardiac pacemaker Allergy to study treatments or its/their excipients, to opioids / opiates, sugammadex, muscle relaxants or their excipients, or other medication(s) used during general anesthesia Toremifene before or within 24 hours of study drug administration Scheduled for an overnight stay (or >12 hours) in PACU Expected transfer to an Intensive Care Unit after surgery Pregnant, intention to become pregnant between randomization and the Day 30 pregnancy follow-up visit Breast-feeding. Investigational drug(s) within 30 days of randomization on this study Participation in any other clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial Participant or family member is among the personnel of the investigational or Sponsor staff directly involved with this trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex<br>Participants receive sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery | Drug: Sugammadex<br>* sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg depending on level of neuromuscular recovery<br>* Other names: SCH 900616, MK-8616;|
| Active Comparator: Neostigmine/glycopyrrolate<br>Participants receive neostigmine/glycopyrrolate per usual practice | Drug: Neostigmine<br>* neostigmine, per usual practice<br>Drug: Glycopyrrolate<br>* glycopyrrolate per usual practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry | Neuromuscular functioning was monitored by applying four TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB. | At PACU entry on Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time From Start of Study Drug Administration to Operating Room Discharge-ready | The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations. | Day 1 |