Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)

Study Overview
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Brief Summary
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The purpose of this study is to determine the optimal dose of sugammadex when this compound is administered during deep neuromuscular block. Sugammadex is administered shortly (5 minutes) after administration of a high dose (1.2 mg/kg) of the neuromuscular blocking agent rocuronium . Under these circumstance the neuromuscular block is deep. The safety and pharmacokinetics of sugammadex are also studied.

Official Title
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A Multi-Center Randomized Safety Assessor-Blinded Placebo-Controlled Parallel and Dose Escalating Dose-Finding Trial in Subjects of ASA 1 - 2 to Assess the Safety, Efficacy and PK of Sugammadex Administered at 5 Min. After Administration of 1.2 mg/kg Esmeron

Conditions
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Anesthesia, General

Intervention / Treatment
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* Drug: sugammadex
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1 - 2 between the ages of 18 and 64, inclusive Scheduled for surgical procedures with an anticipated duration of anesthesia of at least 90 minutes, without further need for muscle relaxation other than for intubation Scheduled for surgery 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 known to interfere with neuromuscular blocking agents such as anticonvulsants and Mg2+ Subjects who had already participated in CT 19.4.205 Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.205 Female subjects who are pregnant: in females pregnancy was to be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who were not of childbearing potential i.e. at least 2 years postmenopausal or underwent tubal ligation or an hysterectomy Females of childbearing potential not using an acceptable method of birth control: condom or diaphragm with spermicide, vasectomized partner (>6 months), IUD, abstinence Subjects giving breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Placebo Comparator: 1<br>rocuronium + 16.0 mg/kg Org 25969 | Drug: Placebo<br>* After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered<br>|
| Experimental: 2<br>rocuronium + 2.0 mg/kg Org 25969 | Drug: sugammadex<br>* After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered<br>* Other names: Org 25969;|
| Experimental: 3<br>rocuronium + 4.0 mg/kg Org 25969 | Drug: sugammadex<br>* After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered<br>* Other names: Org 25969;|
| Experimental: 4<br>rocuronium + 8.0 mg/kg Org 25969 | Drug: sugammadex<br>* After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered<br>* Other names: Org 25969;|
| Experimental: 5<br>rocuronium + 12.0 mg/kg Org 25969 | Drug: sugammadex<br>* After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6) At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered<br>* Other names: Org 25969;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9. |  | After administration of rocuronium | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7; Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8. |  | After administration of rocuronium |