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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00379613
• Date of registration: 21/09/2006
• Primary sponsor: Schering-Plough
• Public title: Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)(COMPLETED)
• Scientific title: 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
• Date of first enrolment: November 2003
• Target sample size: 45
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00379613
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Netherlands

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Anesthesia, General

Intervention(s)

Drug: Placebo

Drug: sugammadex

Primary Outcome(s)

Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9. [Time Frame: After administration of rocuronium]

Secondary Outcome(s)

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. [Time Frame: After administration of rocuronium]

Secondary ID(s)

19.4.205

Source(s) of Monetary Support

Please refer to primary and secondary sponsors