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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-10

Study Completion Date

2006-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)

NCT00451217

Anesthesia, General

COMPLETED PHASE3

Dose-Finding Trial With Sugammadex Administered at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Participants of ASA Class 1-3 (P05944; MK-8616-024)

NCT00535743

Anesthesia, General

COMPLETED PHASE2

A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)

NCT00552617

Anesthesia, General

COMPLETED PHASE2

Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)

NCT01050543

Neuromuscular Blockade

COMPLETED PHASE3

Comparison of Sugammadex Administered at 1-2 Post Tetanic Counts (PTCs) or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adults Undergoing Elective Open Abdominal Procedure (19.4.334) (P05774)

NCT00675792

Anesthesia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia, General

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sugammadex

2.0 mg/kg Org 25969 (sugammadex)

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

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

Neostigmine

50 ug/kg neostigmine

Group Type ACTIVE_COMPARATOR

neostigmine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sugammadex

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

Intervention Type DRUG

neostigmine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Org 25969 premix neostigmine/glycopyrrolate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No