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: October 10, 2014
Last verified: October 2014

November 22, 2011
October 10, 2014
December 2011
October 2012   (final data collection date for primary outcome 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 [ 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.
Incidence of residual block as defined by a Train-of-Four (TOF) ratio <0.9 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
TOF is a measure of muscle response to 4 consecutive stimuli delivered along the path of a nerve; 4 equal contractions signify no neuromuscular blockade.
Complete list of historical versions of study NCT01479764 on ClinicalTrials.gov Archive Site
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.
Time from start of medication to operating room discharge-ready [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
This is a health outcome measure looking at time and motion parameters that can influence the efficiency of the operating room.
Not Provided
Not Provided
 
Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)
Effect of Sugammadex Compared With Usual Care for Reversal of Neuromuscular Blockade Induced by Rocuronium on Incidence of Residual Blockade at PACU Entry

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Surgical Procedures, Elective
  • Drug: Sugammadex
    sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg depending on level of neuromuscular recovery
    Other Name: SCH 900616, MK-8616
  • Drug: Neostigmine
    neostigmine, per usual practice
  • Drug: Glycopyrrolate
    glycopyrrolate per usual practice
  • Experimental: Sugammadex
    Participants receive sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
    Intervention: Drug: Sugammadex
  • Active Comparator: Neostigmine/glycopyrrolate
    Participants receive neostigmine/glycopyrrolate per usual practice
    Interventions:
    • Drug: Neostigmine
    • Drug: Glycopyrrolate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
November 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01479764
P07981, MK-8616-064
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP