Jay B. Brodsky
Routine Care - Time and Motion
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The main objective of our study is to compare the incidence of residual neuromuscular blockade (muscle relaxation) at the time of the removal of the breathing tube from your windpipe after reversal of rocuronium-induced neuromuscular block with sugammadex compared with neostigmine.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: Sugammadex
- Drug: Neostigmine combined with Glycopyrrolate
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to 65 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
? Male or female subjects who are greater than or equal to 18 and less than or equal to 65 years of age;
? Subjects of ASA Class 1 or 2 or 3;
? Subjects with a Body Mass Index (BMI) of <35 kg/m2;
? Subjects who are scheduled to undergo an elective open abdominal surgical procedure under general anesthesia requiring neuromuscular relaxation using rocuronium bromide (maintenance of neuromuscular blockade if required) for endotracheal intubation and requiring neuromuscular blockade reversal;
? Subjects who are scheduled to undergo a surgical procedure in a position that does not interfere with the use of TOF-Watch? SX;
? Subjects who are scheduled to undergo an elective open abdominal procedure expected to last less than or equal to 4 hours (from start of skin incision to end of last stitch of the skin);
? Subjects who have given written informed consent.
Key Exclusion Criteria:
? Subjects in whom a difficult intubation is expected because of anatomical malformations;
? Subjects known or suspected to have neuromuscular disorders that may impair neuromuscular blockade;
? Subjects known or suspected to have significant renal dysfunction (e.g., creatinine clearance < 30 mL/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 have an allergy to opioids, muscle relaxants or other medications used during general anesthesia;
? Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
? Subjects in whom a pre-established need for post-operative intensive care admission is expected;
? Female subjects who are pregnant;
? Female subjects who are breast-feeding;
? Subjects who have participated in a previous sugammadex clinical trial;
? Subjects who have participated in another investigational drug trial within 30 days before entering into clinical trial unless pre-approved by the sponsor.
Additional Study Details
Official Title:
A multi-center, randomized, parallel group, comparative, active controlled, safety-assessor blinded, anesthesiologist-TOF-Watch? SX blinded trial comparing T4/T1 ratio at time of tracheal extubation using 4 mg.kg-1 sugammadex administered at 1-2 PTCs or better after the last dose of rocuronium...Anticipated start date:
Lead Sponsor:
OrganonInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Single BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- To compare the incidence of residual neuromuscular blockade (muscle relaxation) at the time of the removal of the breathing tube from your windpipe after reversal of rocuronium-induced neuromuscular block with sugammadex compared with neostigmine.
Total Number to be Enrolled:
100Total Number to be Enrolled at Stanford:
20More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
11/18/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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