Status:
COMPLETED
Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Neuromuscular Blockade
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subject...
Eligibility Criteria
Inclusion
- 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
- 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 (P05700) unless pre-approved by the sponsor.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00751179
Start Date
November 1 2008
End Date
December 1 2009
Last Update
June 30 2015
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