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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01479764
First received: November 22, 2011
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Surgical Procedures, Elective
Drug: Sugammadex
Drug: Neostigmine
Drug: Glycopyrrolate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 (Phase 5, Protocol No. P07981 [Also Known as MK 8616-064])

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Neuromuscular functioning was monitored by applying three 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:
  • Time From Start of Study Drug Administration to Operating Room Discharge-ready [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations.


Enrollment: 154
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sugammadex
Participants receive sugammadex, 2 or 4 mg/kg-1, depending on level of neuromuscular recovery
Drug: Sugammadex
sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg-1 depending on level of neuromuscular recovery
Other Name: SCH 900616, MK-8616
Active Comparator: Neostigmine/glycopyrrolate
Participants receive neostigmine/glycopyrrolate per usual practice
Drug: Neostigmine
neostigmine, per usual practice
Drug: Glycopyrrolate
glycopyrrolate per usual practice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01479764     History of Changes
Other Study ID Numbers: P07981, MK-8616-064
Study First Received: November 22, 2011
Results First Received: August 26, 2013
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glycopyrrolate
Neostigmine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 14, 2014