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).

Study Overview

• Status: Completed
• Conditions: Surgical Procedures, Elective
• Intervention / Treatment: Drug: Sugammadex; Drug: Neostigmine; Drug: Glycopyrrolate

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry	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.	At PACU entry on Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Start of Study Drug Administration to Operating Room Discharge-ready	The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations.	Day 1

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2011
• Primary Completion (ACTUAL): October 26, 2012
• Study Completion (ACTUAL): November 5, 2012

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 22, 2011
• First Posted (ESTIMATE): November 24, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Adjuvants, Anesthesia; Cholinesterase Inhibitors; Parasympathomimetics; Glycopyrrolate; Neostigmine
• Other Study ID Numbers: P07981; MK-8616-064 (OTHER: Merck study number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php