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

Phase 3

Completed

Brief Summary: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Sugammadex	Sugammadex	Participants receive sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
Neostigmine/glycopyrrolate	Neostigmine	Participants receive neostigmine/glycopyrrolate per usual practice
Neostigmine/glycopyrrolate	Glycopyrrolate	Participants receive neostigmine/glycopyrrolate per usual practice

Primary Outcome Measures

Name	Time	Method
Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry	At PACU entry on Day 1	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.

Secondary Outcome Measures

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