Reversal With Sugammadex in Short Procedures in Out-Patient Surgicenters as Compared to Succinylcholine Alone (19.4.319) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00751179

Purpose

A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective of this study is to evaluate the increase in plasma potassium following succinylcholine alone and after treatment with the combination of rocuronium and sugammadex.

Condition	Intervention	Phase
Neuromuscular Blockade	Drug: rocuronium Drug: sugammadex Drug: succinylcholine	Phase III

Drug Information available for: Rocuronium ORG 9426 Sugammadex Chlorides Succinylcholine Succinylcholine chloride Suxamethonium bromide Benzocaine Sugammadex Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Parallel Group, Comparative, Active Controlled, Safety Assessor Blinded Trial in Adult Subjects Comparing Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Subjects Undergoing Short Surgical Procedures in Out-Patient Surgicenters.

Further study details as provided by Organon:

Primary Outcome Measures:

To evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, and succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters [ Time Frame: Peri-Anesthetic Period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the safety of the combination of rocuronium and a single dose of 4.0 mg.kg-1 sugammadex for reversal as compared to the use of 1.0 mg.kg-1 succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters [ Time Frame: Peri-Anesthetic Period through Follow-up Period ] [ Designated as safety issue: Yes ]
To evaluate the efficacy of reversal with 4.0 mg.kg-1 of sugammadex after neuromuscular blockade induced by rocuronium [ Time Frame: Peri-Anesthetic Period ] [ Designated as safety issue: Yes ]
To evaluate spontaneous recovery after neuromuscular block induced by succinylcholine. [ Time Frame: Peri-Anesthetic Period ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
1: Active Comparator Rocuronium - Sugammadex 4.0 mg.kg-1	Drug: rocuronium A single bolus intubation dose of 0.6 mg.kg-1 rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg.kg-1 rocuronium will be administered to maintain the neuromuscular block. Drug: sugammadex At the end of the surgical procedure at a target depth of neuromuscular blockade of at least 1-2 PTC, 4.0 mg.kg-1 of sugammadex will be administered.
2: Active Comparator Succinylcholine 1.0 mg.kg-1	Drug: succinylcholine A single bolus intubation dose of 1.0 mg.kg-1 succinylcholine will be administered following induction of anesthesia and the subject is allowed to recover spontaneously from the neuromuscular blockade.

Arms

Assigned Interventions

1: Active Comparator

Rocuronium - Sugammadex 4.0 mg.kg-1

Drug: rocuronium

A single bolus intubation dose of 0.6 mg.kg-1 rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg.kg-1 rocuronium will be administered to maintain the neuromuscular block.

Drug: sugammadex

At the end of the surgical procedure at a target depth of neuromuscular blockade of at least 1-2 PTC, 4.0 mg.kg-1 of sugammadex will be administered.

2: Active Comparator

Succinylcholine 1.0 mg.kg-1

Drug: succinylcholine

A single bolus intubation dose of 1.0 mg.kg-1 succinylcholine will be administered following induction of anesthesia and the subject is allowed to recover spontaneously from the neuromuscular blockade.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female subjects >=18 years of age;
ASA Class 1-3;
Subjects with a Body Mass Index (BMI) of < 35 kg/m^2 ;
Subjects scheduled to undergo an elective short procedure with general anesthesia requiring neuromuscular relaxation and endotracheal intubation in outpatient surgicenters;
Subjects scheduled to undergo an elective surgical procedure expected to last 1.5 hours or less (from end of intubation to end of suturing/stapling of skin);
Subjects who are scheduled to undergo an elective surgical procedures that allows access to the arm for TOF-Watch® SX monitoring;
Subjects who have given written informed consent.

Exclusion Criteria:

Subjects known to have ischemic heart disease or a history of myocardial infarction;
Subjects in whom a difficult intubation is expected because of anatomical malformations;
Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemakers);
Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis);
Subjects who would require the use of pneumatic tourniquet during the surgical procedure;
Subjects known or suspected to have significant renal dysfunction (e.g., creatinine clearance < 30 mL per min);
Subjects known or suspected to have significant hepatic dysfunction;
Subjects known or suspected to have a (family) history of malignant hyperthermia;
Subjects known or suspected to be hypersensitive to sugammadex or other cyclodextrins or rocuronium or any of its excipients;
Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants, or other medications used during general anesthesia;
Subjects for whom a pre-established need for post operative intensive care admission and/or hospital admission is expected;
Subjects for whom an intra operative IV administration of fluids that contain potassium is expected;
Female subjects who are pregnant;
Female subjects who are breast-feeding;
Subjects who have participated in a previous sugammadex trial;
Subjects who have participated in another investigational drug trial within 30 days before entering into clinical trial (CT) 19.4.319 unless pre-approved by the sponsor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751179

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

United States, Florida
Investigational Site 109	Recruiting
Tampa, Florida, United States, 33606
United States, Michigan
Investigational Site 101	Recruiting
Royal Oak, Michigan, United States, 48073-6769

Sponsors and Collaborators

Organon

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.319, P05700
Study First Received:	September 10, 2008
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00751179
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Succinylcholine
Bromides
Rocuronium
Benzocaine

Additional relevant MeSH terms:

Neuromuscular Nondepolarizing Agents
Physiological Effects of Drugs
Neuromuscular Depolarizing Agents
Neuromuscular Agents

Neuromuscular Blocking Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009