- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00451217
Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)
February 15, 2019 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
198
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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 Names:
|
Active Comparator: Rocuronium + Neostigmine
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Other Names:
|
Experimental: Vecuronium + Sugammadex
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
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 Names:
|
Active Comparator: Vecuronium + Neostigmine
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7
|
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.
|
Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8
|
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
|
Day 1
|
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
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Khuenl-Brady KS, Wattwil M, Vanacker BF, Lora-Tamayo JI, Rietbergen H, Alvarez-Gomez JA. Sugammadex provides faster reversal of vecuronium-induced neuromuscular blockade compared with neostigmine: a multicenter, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):64-73. doi: 10.1213/ane.0b013e3181ac53c3. Epub 2009 Aug 27.
- Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, Prins ME. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. Eur J Anaesthesiol. 2010 Oct;27(10):874-81. doi: 10.1097/EJA.0b013e32833d56b7.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2005
Primary Completion (Actual)
March 6, 2006
Study Completion (Actual)
March 6, 2006
Study Registration Dates
First Submitted
March 22, 2007
First Submitted That Met QC Criteria
March 22, 2007
First Posted (Estimate)
March 23, 2007
Study Record Updates
Last Update Posted (Actual)
March 4, 2019
Last Update Submitted That Met QC Criteria
February 15, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Enzyme Inhibitors
- Adjuvants, Anesthesia
- Cholinesterase Inhibitors
- Parasympathomimetics
- Glycopyrrolate
- Neostigmine
Other Study ID Numbers
- P05960
- 19.4.301 (Other Identifier: Organon Protocol Number)
- MK-8616-033 (Other Identifier: Merck Protocol Number)
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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