Comparison of Rocuronium and Org 25969 With Cisatracurium and Neostigmine (19.4.310)(P05931)

Comparison of Rocuronium and Org25969 With Cisatracurium and Neostigmine When Neuromuscular Block is Reversed at Reappearance of T2

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00451100

Enrollment

Registered

2007-03-23

Start date

2005-11-10

Completion date

2006-08-29

Last updated

2019-11-15

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

Conditions

Anesthesia, General

Brief summary

The purpose of this study was to demonstrate in adult patients a faster recovery from a neuromuscular block with 2.0 mg/kg Org 25969 (sugammadex) after rocuronium as compared to 50 ug/kg neostigmine after cisatracurium when administered at reappearance of T2

Interventions

DRUGSugammadex

Subjects received a bolus dose of 0.6 mg/kg rocuronium. After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg Org 25969 was to be administered

DRUGneostigmine

Subjects received a bolus dose of 0.15 mg/kg cisatracurium. After the last dose of cisatracurium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered. In accordance to the labeling of neostigmine, a maximum of 5 mg neostigmine was to be administered

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects of ASA 1 - 4; * Subjects above or equal to the age of 18; * Scheduled for surgical procedures with a general anesthesia requiring neuromuscular relaxation with the use of rocuronium or cisatracurium; * Scheduled for surgical procedures 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 in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+; * Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated; * Subjects who had already participated in an Org25969 trial; * Subjects who had 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: condom or using only hormonal contraception as birth control; * Female subjects who were breast -feeding.

Design outcomes

Primary

Measure	Time frame
Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9	After surgery

Secondary

Measure	Time frame
Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8	After surgery
Assessment of clinical signs of recovery (level of consciousness, 5 sec head lift, and general muscle weakness)	after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026