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.

November 22, 2011
November 24, 2011
August 26, 2013
December 31, 2013
June 6, 2017
December 2, 2011
October 26, 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 ]
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.
Incidence of residual block as defined by a Train-of-Four (TOF) ratio <0.9 [ Time Frame: Day 1 ]
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 Archive Site
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.
Time from start of medication to operating room discharge-ready [ Time Frame: Day 1 ]
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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
    • Drug: Neostigmine
    • Drug: Glycopyrrolate
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 5, 2012
October 26, 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
MK-8616-064 ( Other Identifier: Merck study number )
Not Provided
Plan to Share IPD: Yes
Plan Description:

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2017

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