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

Surgical Procedures, Elective Clinical Trial

Official title:

Effect of Sugammadex Compared With Usual Care for Reversal of Neuromuscular Blockade Induced by Rocuronium on Incidence of Residual Blockade at PACU Entry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479764
• Other study ID #: P07981
• Secondary ID: MK-8616-064
• Status: Completed
• Phase: Phase 3
• First received: November 22, 2011
• Last updated: June 5, 2015
• Start date: December 2011
• Est. completion date: November 2012

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgical Procedures, Elective

Intervention

Drug:
• Sugammadex
sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg depending on level of neuromuscular recovery
• Neostigmine
neostigmine, per usual practice
• Glycopyrrolate
glycopyrrolate per usual practice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No