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Trial record 33 of 186 for:    GLYCOPYRROLATE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01479764
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : December 31, 2013
Last Update Posted : June 6, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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).

Condition or disease Intervention/treatment Phase
Surgical Procedures, Elective Drug: Sugammadex Drug: Neostigmine Drug: Glycopyrrolate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : December 2, 2011
Actual Primary Completion Date : October 26, 2012
Actual Study Completion Date : November 5, 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sugammadex
Participants receive sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
Drug: Sugammadex
sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg 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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01479764     History of Changes
Other Study ID Numbers: P07981
MK-8616-064 ( Other Identifier: Merck study number )
First Posted: November 24, 2011    Key Record Dates
Results First Posted: December 31, 2013
Last Update Posted: June 6, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Additional relevant MeSH terms:
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Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists