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Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)

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ClinicalTrials.gov Identifier: NCT00451217
Recruitment Status : Completed
First Posted : March 23, 2007
Results First Posted : February 18, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg neostigmine.

Condition or disease Intervention/treatment Phase
Anesthesia, General Drug: Sugammadex Drug: Neostigmine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi -Center Randomized Parallel Group Comparative Active Controlled Safety Assessor Blinded Phase 3a Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agents of a Neuromuscular Block Induced by Rocuronium or Vecuronium at Reappearance of T2
Actual Study Start Date : November 17, 2005
Actual Primary Completion Date : March 6, 2006
Actual Study Completion Date : March 6, 2006


Arm Intervention/treatment
Experimental: Rocuronium + Sugammadex
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
Drug: Sugammadex
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered
Other Name: Org 25969

Active Comparator: Rocuronium + Neostigmine
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
Drug: Neostigmine
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Other Name: premix neostigmine/glycopyrrolate

Experimental: Vecuronium + Sugammadex
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
Drug: Sugammadex
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered
Other Name: Org 25969

Active Comparator: Vecuronium + Neostigmine
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
Drug: Neostigmine
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Other Name: premix neostigmine/glycopyrrolate




Primary Outcome Measures :
  1. Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9. [ Time Frame: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 ]
    Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) 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 neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.


Secondary Outcome Measures :
  1. Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 [ Time Frame: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 ]
    Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) 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. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.

  2. Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 [ Time Frame: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 ]
    Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) 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. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.

  3. Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation [ Time Frame: Day 1 ]
    After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness

  4. Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room [ Time Frame: Day 1 ]
    Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is of American Society of Anesthesiologists (ASA) 1 - 4;
  • Is above or equal to the age of 18;
  • Scheduled for surgical procedures with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;
  • Scheduled for surgical procedure in supine position;
  • Given written informed consent.

Exclusion Criteria:

  • Participants in whom a difficult intubation because of anatomical malformations was expected;
  • Is known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction;
  • Is known or suspected to have a (family) history of malignant hyperthermia;
  • Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
  • Is receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
  • Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
  • Had already participated in a sugammadex trial;
  • Had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into P05960.
  • Females who are pregnant:
  • Females of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
  • Females who were breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451217


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00451217     History of Changes
Other Study ID Numbers: P05960
19.4.301 ( Other Identifier: Organon Protocol Number )
MK-8616-033 ( Other Identifier: Merck Protocol Number )
First Posted: March 23, 2007    Key Record Dates
Results First Posted: February 18, 2019
Last Update Posted: March 4, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Glycopyrrolate
Rocuronium
Vecuronium Bromide
Neostigmine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Nicotinic Antagonists