Comparing 4.0 mg.Kg-1 Sugammadex With Placebo During Profound Neuromuscular Blockade (19.4.316)(P05767)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00758485

Purpose

The current trial was designed to demonstrate faster recovery in subjects undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a T4/T1 ratio of 0.9, after reversal of a target depth of neuromuscular blockade of 1-2 PTC by 4.0 mg.kg-1 sugammadex compared to placebo, to evaluate the safety of 4.0 mg.kg-1 sugammadex and to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these subjects.

Condition	Intervention	Phase
Anesthesia, General Neuromuscular Relaxation	Drug: Sugammadex Drug: 0.9% NaCl	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Safety-assessor Blinded Trial Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in Adult Subjects Scheduled for Surgery Requiring Profound Neuromuscular Blockade.

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Sugammadex

U.S. FDA Resources

Further study details as provided by Organon:

Primary Outcome Measures:

Time from start of administration of IMP to recovery of the T4/T1 ratio to 0.9 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time from start of administration of IMP to recovery of the T4/T1 ratio to 0.7 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
Time from start of administration of IMP to recovery of the T4/T1 ratio to 0.8 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	December 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
sugammadex: Experimental At a target depth of blockade of 1-2 PTC after the last dose of rocuronium, sugammadex will be administered.	Drug: Sugammadex At a target depth of blockade of 1-2 PTC after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex (dosed on the actual body weight of the subject) will be administered as per randomization schedule, within 10 seconds into a fast running venous infusion.
Placebo: Placebo Comparator At a target depth of blockade of 1-2 PTC after the last dose of rocuronium, placebo will be administered.	Drug: 0.9% NaCl After the last dose of rocuronium has been administered, the subject will receive a randomized dose of placebo at a target depth of neuromuscular blockade of 1-2 PTC. The bolus dose will be administered within 10 seconds into a fast running intravenous infusion. The volume of placebo should be identical to a volume of a dose of 4.0 mg.kg-1 sugammadex (dosed on the actual body weight of the subjects as if (s)he were randomized to sugammadex).

Arms

Assigned Interventions

sugammadex: Experimental

At a target depth of blockade of 1-2 PTC after the last dose of rocuronium, sugammadex will be administered.

Drug: Sugammadex

At a target depth of blockade of 1-2 PTC after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex (dosed on the actual body weight of the subject) will be administered as per randomization schedule, within 10 seconds into a fast running venous infusion.

Placebo: Placebo Comparator

At a target depth of blockade of 1-2 PTC after the last dose of rocuronium, placebo will be administered.

Drug: 0.9% NaCl

After the last dose of rocuronium has been administered, the subject will receive a randomized dose of placebo at a target depth of neuromuscular blockade of 1-2 PTC. The bolus dose will be administered within 10 seconds into a fast running intravenous infusion. The volume of placebo should be identical to a volume of a dose of 4.0 mg.kg-1 sugammadex (dosed on the actual body weight of the subjects as if (s)he were randomized to sugammadex).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects of ASA (American Society of Anesthesiologists) class 1, 2 or 3, age >= 18 years, who are scheduled to undergo a surgery requiring profound neuromuscular blockade such as cardiovascular, gynaecologic, neurologic and thoracic surgical procedures under general anesthesia requiring neuromuscular relaxation with rocuronium for endotracheal intubation and if applicable maintenance of neuromuscular blockade in a position allowing neuromuscular monitoring and who have given written informed consent.

Exclusion Criteria:

Subjects known or suspected to have neuromuscular disorders affecting Neuromuscular Blockade (NMB)

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.316, EudraCT #: 2008-002518-23;, P05767
Study First Received:	September 23, 2008
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00758485 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Rocuronium

ClinicalTrials.gov processed this record on September 11, 2009