Clinical trial NCT01479764: Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)
Official title: Effect of Sugammadex Compared With Usual Care for Reversal of Neuromuscular Blockade Induced by Rocuronium on Incidence of Residual Blockade at PACU Entry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Procedures, Elective
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-11-24
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry
timeFrame: At PACU entry on Day 1
Secondary outcomes:
measure: Time From Start of Study Drug Administration to Operating Room Discharge-ready
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
citation: Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, Staehr-Rye AK, Eikermann M. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.