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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Surgical Procedures, Elective

Treatments: Drug: Glycopyrrolate; Drug: Sugammadex; Drug: Neostigmine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01479764

P07981

MK-8616-064 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Sugammadex

Experimental group

Description:

Participants receive sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery

Treatment:

Drug: Sugammadex

Neostigmine/glycopyrrolate

Active Comparator group

Description:

Participants receive neostigmine/glycopyrrolate per usual practice

Treatment:

Drug: Glycopyrrolate

Drug: Neostigmine