Comparison of rocuronium and Org 25969 with cis-atracurium and neostigmine when neuromuscular block is reversed at reappearance of T2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001792-35-GB

Enrollment

Registered

2005-08-25

Start date

2005-09-28

Completion date

Unknown

Last updated

2019-11-25

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:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Subjects of ASA class 1 to 4, above or equal to the age of 18 years; • Subjects scheduled for surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium or cis-atracurium; • Subjects scheduled for surgical procedures in supine position; • 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Subjects in whom a difficult intubation because of anatomical malformations is expected; • Subjects known or suspected to have neuromuscular disorders impairing 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 NMBA, such as anticonvulsants and Mg2+; • Subjects contra-indicated for the use of neostigmine and/or glycopyrrolate; • Subjects who have already participated in an Org 25969 trial; • Subjects who have 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 or using only hormonal contraception as birth control; • Female subjects who are breast-feeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: To show a faster recovery of neuromuscular block with Org 25969 after rocuronium as compared to neostigmine after cis-atracurium when administered at reappearance of T2.; Secondary Objective: • To evaluate the safety of a single dose of 2.0 mg.kg-1 Org 25969 and 50 µg.kg-1 neostigmine administered in adult subjects. • To show a faster onset of neuromuscular block after 0.6 mg.kg-1 rocuronium as compared to 0.15 mg.kg-1 cis-atracurium. ;Primary end point(s): Time from start of administration of Org 25969/neostigmine to recovery of the T4/T1 ratio to 0.9 (Note: The recovery from NMB at reappearance of T2 between Org 25969 and neostigmine will be compared).	—

Measure

Time frame

Main Objective: To show a faster recovery of neuromuscular block with Org 25969 after rocuronium as compared to neostigmine after cis-atracurium when administered at reappearance of T2.; Secondary Objective: • To evaluate the safety of a single dose of 2.0 mg.kg-1 Org 25969 and 50 µg.kg-1 neostigmine administered in adult subjects. • To show a faster onset of neuromuscular block after 0.6 mg.kg-1 rocuronium as compared to 0.15 mg.kg-1 cis-atracurium. ;Primary end point(s): Time from start of administration of Org 25969/neostigmine to recovery of the T4/T1 ratio to 0.9 (Note: The recovery from NMB at reappearance of T2 between Org 25969 and neostigmine will be compared).

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Countries

Italy, United Kingdom

Outcome results