Safety and Efficacy Evaluation of Sugammadex in Cardiac Patients (19.4.309)(P05934)

A Multi -Center, Randomized, Parallel-Group, Placebo-Controlled, Safety Assessor-Blinded Trial, Evaluating the Safety and Efficacy of Sugammadex in Cardiac Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00420680

Enrollment

120

Registered

2007-01-11

Start date

2005-11-07

Completion date

2006-08-01

Last updated

2017-08-22

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

Conditions

Anesthesia

Brief summary

The purpose of this study is to evaluate the safety of 2.0 mg/kg and 4.0 mg/kg sugammadex given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium in cardiac patients

Interventions

DRUGSugammadex

Sugammadex, 2.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium

DRUGPlacebo

Placebo given at reappearance of T2 after 0.6 mg/kg rocuronium

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

* Cardiac patients of NYHA Class II to III * ASA class maximally 4 * Age at least 18 * Scheduled for elective, non-cardiac surgery under general anesthesia with propofol in the supine position, with planned muscle relaxation using rocuronium and allowing for 12-lead ECG assessment during surgery; * Given written informed consent.

Exclusion criteria

* Disorders interfering with the reliability of the assessments (e.g. ECG measurements), such as paroxysmal atrial fibrillation or the presence of a pacemaker * Known or suspected neuromuscular disorders impairing NMB * Known or suspected significant renal dysfunction * Known or suspected (family) history of malignant hyperthermia * Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia * Intended) use of medication expected to interfere with the effect of rocuronium as given in this trial, based on the dose and/or the time of administration (such as antibiotics, anticonvulsants and Mg2+ ) * Pregnancy (pregnancy to be excluded for women both from medical history and by an hCG test within 24 h before surgery, except for women who were not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or a hysterectomy) * Childbearing potential without using any method of birth control or using only hormonal contraception as birth control (subjects were allowed to participate if they were willing to use a condom, or a diaphragm with spermicide, or IUD, or have a vasectomized partner (\>6 months) or abstinence, for one month after participation in the trial) * Breast -feeding * Prior participation in any trial with Org 25969 * Participation in another clinical trial not pre -approved by Organon, within 30 days of entering into trial 19.4.309

Design outcomes

Primary

Measure	Time frame
to evaluate the safety of 2.0 and 4.0 mg/kg sugammadex in cardiac patients compared to placebo	after surgery

Secondary

Measure	Time frame
to evaluate the time to recovery from a neuromuscular block induced by rocuronium after reversal at reappearance of T2 by 2.0 and 4.0 mg/kg sugammadex in cardiac patients	after surgery

Outcome results

None listed

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