Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)
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Purpose
The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects for registration purposes in China.
| Condition | Intervention | Phase |
|---|---|---|
|
Anesthesia, General Neuromuscular Blockade |
Drug: Sugammadex Drug: neostigmine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-center, Randomized, Parallel-group, Active-controlled, Safety-assessor Blinded Trial, Comparing the Efficacy and Safety of 2.0 mg.Kg-1 Sugammadex With 50 μg.Kg-1 Neostigmine Administered at Reappearance of T2 After Rocuronium in Chinese and European ASA I-III Subjects Undergoing Elective Surgery Under Propofol Anesthesia |
- Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9. [ Time Frame: start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade ] [ Designated as safety issue: No ]
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. Nerve stimulation was to continue until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached >= 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.
The primary analysis was the comparison between sugammadex & neostigmine among Chinese subjects; other comparisons were secondary.
- Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8. [ Time Frame: start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade ] [ Designated as safety issue: No ]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. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.
| Enrollment: | 308 |
| Study Start Date: | January 2010 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sugammadex in Caucasian Subjects
At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
|
Drug: Sugammadex
After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 2.0 mg/kg sugammadex was administered.
Other Name: Org 25969, Bridion®
|
|
Active Comparator: Neostigmine in Caucasian Subjects
At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
|
Drug: neostigmine
After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 50 µg/kg neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
Other Name: Neostigmine with atropine
|
|
Experimental: Sugammadex in Chinese Subjects
At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
|
Drug: Sugammadex
After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 2.0 mg/kg sugammadex was administered.
Other Name: Org 25969, Bridion®
|
|
Active Comparator: Neostigmine in Chinese Subjects
At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
|
Drug: neostigmine
After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 50 µg/kg neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
Other Name: Neostigmine with atropine
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).
For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.
Exclusion Criteria:
-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the (family of) study/sponsor staff.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00825812 History of Changes |
| Other Study ID Numbers: | 19.4.324, P05768 |
| Study First Received: | January 15, 2009 |
| Results First Received: | July 22, 2011 |
| Last Updated: | July 22, 2011 |
| Health Authority: | Denmark: Danish Medicines Agency China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Atropine Neostigmine Rocuronium Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents Cardiovascular Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents |
Respiratory System Agents Mydriatics Parasympatholytics Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinesterase Inhibitors Enzyme Inhibitors Parasympathomimetics Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents |
ClinicalTrials.gov processed this record on May 23, 2013