Reversal With Sugammadex in Short Procedures in Out-patient Surgicenters as Compared to Succinylcholine Alone (19.4.319)(P05700)

Condition(s) targeted: Neuromuscular Blockade

Intervention: rocuronium (Drug); sugammadex (Drug); succinylcholine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Schering-Plough

Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

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 is 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.

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.

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

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

To evaluate the efficacy of reversal with 4.0 mg.kg-1 of sugammadex after neuromuscular blockade induced by rocuronium

To evaluate spontaneous recovery after neuromuscular block induced by succinylcholine.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Investigational Site 104, Los Angeles, California 90095, United States; Recruiting

Investigational Site 109, Tampa, Florida 33606, United States; Recruiting

Investigational Site 110, Jacksonville, Florida 32209, United States; Recruiting

Investigational Site 112, Boston, Massachusetts 02115, United States; Recruiting

Investigational Site 101, Royal Oak, Michigan 48073-6769, United States; Recruiting

Investigational Site 106, New York, New York 10065, United States; Recruiting

Investigational Site 111, Chapel Hill, North Carolina 27599, United States; Recruiting

Investigational Site 102, Cleveland, Ohio 44195, United States; Recruiting

Investigational Site 107, Philadelphia, Pennsylvania 19102, United States; Recruiting

Investigational Site 117, Pittsburgh, Pennsylvania 15232, United States; Recruiting

Investigational Site 116, Montreal, Quebec H3T 1E2, Canada; Recruiting

Investigational Site 103, Salt Lake City, Utah 84132, United States; Recruiting

Investigational Site 113, Burlington, Vermont 05401, United States; Recruiting

Investigational Site 105, Seattle, Washington 98195, United States; Recruiting

Starting date: November 2008
Ending date: November 2009
Last updated: October 2, 2009