Comparison of Rocuronium and Org 25969 With Cisatracurium and Neostigmine (19.4.310)(P05931)

Study Overview
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Brief Summary
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The purpose of this study was to demonstrate in adult patients a faster recovery from a neuromuscular block with 2.0 mg/kg Org 25969 (sugammadex) after rocuronium as compared to 50 ug/kg neostigmine after cisatracurium when administered at reappearance of T2

Official Title
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Comparison of Rocuronium and Org25969 With Cisatracurium and Neostigmine When Neuromuscular Block is Reversed at Reappearance of T2

Conditions
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Anesthesia, General

Intervention / Treatment
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* Drug: Sugammadex
* Drug: neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of ASA 1 - 4; Subjects above or equal to the age of 18; Scheduled for surgical procedures with a general anesthesia requiring neuromuscular relaxation with the use of rocuronium or cisatracurium; Scheduled for surgical procedures in supine position; Given written informed consent. Exclusion Criteria: Subjects in whom a difficult intubation because of anatomical malformations was expected; Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction; Subjects known or suspected to have a (family) history of malignant hyperthermia; Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia; Subjects receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+; Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated; Subjects who had already participated in an Org25969 trial; Subjects who had participated in another clinical trial (not pre-approved by NV Organon) within 30 days of entering into CT 19.4.310. Female subjects who are pregnant: Female subjects of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control; Female subjects who were breast -feeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex<br>2.0 mg/kg Org 25969 (sugammadex) | Drug: Sugammadex<br>* Subjects received a bolus dose of 0.6 mg/kg rocuronium. After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg Org 25969 was to be administered<br>* Other names: Org 25969;|
| Active Comparator: Neostigmine<br>50 ug/kg neostigmine | Drug: neostigmine<br>* Subjects received a bolus dose of 0.15 mg/kg cisatracurium. After the last dose of cisatracurium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered. In accordance to the labeling of neostigmine, a maximum of 5 mg neostigmine was to be administered<br>* Other names: premix neostigmine/glycopyrrolate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9 |  | After surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8 |  | After surgery | 
| Assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, and general muscle weakness) |  | after surgery |