Status:
COMPLETED
Comparison of Sugammadex Administered at 1-2 Post Tetanic Counts (PTCs) or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adults Undergoing Elective Open Abdominal Procedure (19.4.334) (P05774)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anesthesia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to compare the incidence of residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade...
Detailed Description
Undetected residual neuromuscular blockade is common in the post-anesthesia care unit (PACU). In fact, 16%-42% of patients receiving intermediate-acting muscle relaxants in the operating room have T...
Eligibility Criteria
Inclusion
- male or females who are \>= 18 and \<= 65 years of age
- classified by the American Society of Anesthesiologists (ASA) as Class 1 or 2 or 3;
- Body Mass Index (BMI) of \<35 kg/m\^2;
- is 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;
- is scheduled to undergo a surgical procedure in a position that does not interfere with the use of TOF-Watch® SX;
- is scheduled to undergo an elective open abdominal procedure expected to last \<=4 hours (from start of skin incision to end of last stitch of the skin);
- have given written informed consent.
Exclusion
- participants for whom a difficult intubation is expected because of anatomical malformations;
- is known or suspected to have neuromuscular disorders that may impair neuromuscular blockade;
- is known or suspected to have significant renal dysfunction (e.g., creatinine clearance \< 30 mL/min) ;
- is known or suspected to have significant hepatic dysfunction;
- is known or suspected to have a (family) history of malignant hyperthermia;
- is known or suspected to have an allergy to opioids, muscle relaxants or other medications used during general anesthesia;
- participants for whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
- participants for whom a pre-established need for postoperative intensive care admission is expected;
- pregnant or breast-feeding females;
- have participated in a previous sugammadex clinical trial;
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00675792
Start Date
May 1 2008
End Date
September 1 2008
Last Update
March 13 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.