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Completed

NCT Number: NCT01479764

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

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).

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Key information

Conditions

Surgical Procedures, Elective

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg depending on level of neuromuscular recovery

Other names: SCH 900616, MK-8616

Neostigmine

Drug

neostigmine, per usual practice

Glycopyrrolate

Drug

glycopyrrolate per usual practice

Primary outcomes

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

    Time frame: 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 outcomes

  1. Time From Start of Study Drug Administration to Operating Room Discharge-ready

    Time frame: Day 1

    The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 24, 2011
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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