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

NCT ID: NCT01479764

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-02
• Study Completion Date: 2012-11-05

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).

Conditions

Surgical Procedures, Elective

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sugammadex

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

Group Type: EXPERIMENTAL

Sugammadex

Intervention Type: DRUG

sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg depending on level of neuromuscular recovery

Neostigmine/glycopyrrolate

Participants receive neostigmine/glycopyrrolate per usual practice

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: DRUG

neostigmine, per usual practice

Glycopyrrolate

Intervention Type: DRUG

glycopyrrolate per usual practice

Interventions

Sugammadex

sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg depending on level of neuromuscular recovery

Intervention Type: DRUG

Neostigmine

neostigmine, per usual practice

Intervention Type: DRUG

Glycopyrrolate

glycopyrrolate per usual practice

Intervention Type: DRUG

Other Intervention Names

SCH 900616, MK-8616

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 25935840 (View on PubMed)

Other Identifiers

MK-8616-064

Identifier Type: OTHER

Identifier Source: secondary_id

P07981

Identifier Type: -

Identifier Source: org_study_id