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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Anesthesia, General

Treatments: Drug: sugammadex; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00379613

19.4.205

P05942

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 5 patient groups, including a placebo group

1

Placebo Comparator group

Description:

rocuronium + 16.0 mg/kg Org 25969

Treatment:

Drug: Placebo

2

Experimental group

Description:

rocuronium + 2.0 mg/kg Org 25969

Treatment:

Drug: sugammadex

3

Experimental group

Description:

rocuronium + 4.0 mg/kg Org 25969

Treatment:

Drug: sugammadex

4

Experimental group

Description:

rocuronium + 8.0 mg/kg Org 25969

Treatment:

Drug: sugammadex

5

Experimental group

Description:

rocuronium + 12.0 mg/kg Org 25969

Treatment:

Drug: sugammadex