A multi-center, randomized, parallel-group, safety assessor-blinded trial comparing efficacy and safety of 4.0 mg.kg-1 Org 25969, administered at T1 3-10% after continuous infusion of rocuronium, and pharmacokinetics of rocuronium, between subjects receiving maintenance anesthesia using propofol and subjects receiving maintenance anesthesia using sevoflurane.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004072-12-DK

Enrollment

Registered

2006-10-05

Start date

2007-02-01

Completion date

Unknown

Last updated

2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Product Name: Org 25969 Product Code: Org 25969 Pharmaceutical Form: Solution for injection INN or Proposed INN: sugammadex CAS Number: 343306-79-6 Current Sponsor code: Org 25969 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects at least 20 years but under 65 years of age; 2. Subjects of ASA class 1-3; 3. Subjects scheduled for a surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of a NMBA, with an anticipated duration of surgery between 2 and 5 hours; 4. Subjects scheduled for a surgical procedure in supine position; 5. Subjects who have given written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Subjects in whom difficult intubation is expected because of anatomical malformations; 2. Subjects known or suspected to have neuromuscular disorders affecting NMB and/or significant renal dysfunction; 3. Subjects known or suspected to have a (family) history of malignant hyperthermia; 4. Subjects known or suspected to have an allergy to medications used during general anesthesia; 5. Subjects receiving medication interfering with NMBAs, such as antibiotics, anticonvulsants and Mg2+; based on the dose and time of administration; 6. Pregnant or lactating females; 7. Female subjects of childbearing potential not using any birth control or using only hormonal contraception as birth control; 8. Subjects who have already participated in trial CT 19.4.312, or in another trial with Org 25959; 9. Subjects who have participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into CT 19.4.312.

Design outcomes

Primary

Measure	Time frame
Main Objective: To show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg.kg-1 Org 25969, administered at T1 3-10% after continuous infusion of rocuronium, between subjects receiving maintenance anesthesia using propofol and subjects receiving sevoflurane.;Secondary Objective: • To investigate the safety of a single dose of 4.0 mg.kg-1 Org 25969, administered at T1 3-10% after continuous infusion of rocuronium, under either propofol or sevoflurane anesthesia. • To compare the plasma levels of rocuronium in subjects after continuous infusion of rocuronium and before the administration of Org 25969, under either propofol or sevoflurane anesthesia. ;Primary end point(s): Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9.	—

Measure

Time frame

Main Objective: To show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg.kg-1 Org 25969, administered at T1 3-10% after continuous infusion of rocuronium, between subjects receiving maintenance anesthesia using propofol and subjects receiving sevoflurane.;Secondary Objective: • To investigate the safety of a single dose of 4.0 mg.kg-1 Org 25969, administered at T1 3-10% after continuous infusion of rocuronium, under either propofol or sevoflurane anesthesia. • To compare the plasma levels of rocuronium in subjects after continuous infusion of rocuronium and before the administration of Org 25969, under either propofol or sevoflurane anesthesia. ;Primary end point(s): Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9.

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Countries

Denmark, Germany

Outcome results