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

NCT01479764 | Completed Phase 3 Results

• 2 other identifiers: P07981MK-8616-064
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time From Start of Study Drug Administration to Operating Room Discharge-ready

  Day 1

Study Arms (2)

Sugammadex

EXPERIMENTAL

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

Drug: Sugammadex

Neostigmine/glycopyrrolate

ACTIVE COMPARATOR

Participants receive neostigmine/glycopyrrolate per usual practice

Drug: Neostigmine; Drug: Glycopyrrolate

Interventions

Sugammadex DRUG

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

Also known as: SCH 900616, MK-8616

Sugammadex

Neostigmine DRUG

neostigmine, per usual practice

Neostigmine/glycopyrrolate

Glycopyrrolate DRUG

glycopyrrolate per usual practice

Neostigmine/glycopyrrolate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2.

  PMID: 25935840 RESULT

MeSH Terms

Interventions

Sugammadex; Neostigmine; Glycopyrrolate

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Vice President, Late Stage Development Group Leader
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: December 2, 2011
• Primary Completion: October 26, 2012
• Study Completion: November 5, 2012
• Last Updated: June 6, 2017
• Results First Posted: December 31, 2013

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share