This randomized phase III trial studies how well sugammadex works compared to neostigmine and glycopyrrolate in reducing the time to muscle strength recovery after surgery in patients undergoing surgery. Doctors use drugs called neuromuscular blockers in order to relax muscles during surgery. Drugs such as sugammadex or neostigmine and glycopyrrolate work to reverse the effects of the neuromuscular blockers and allows strength to return to the muscles after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03116997.
PRIMARY OBJECTIVES:
I. To compare the difference in duration from administration of neuromuscular blockade (NMB) reversal agent to the time the patient is ready for discharge from Post Anesthesia Care Unit (PACU) after NMB reversal with sugammadex versus neostigmine.
SECONDARY OBJECTIVES:
I. To compare the patient-reported quality of post operative recovery using standard symptoms of subclinical weakness or paralysis after NMB reversal with sugammadex (SUG) versus (vs) neostigmine (NEO), specifically: a. difficulty with breathing; b. presence of diplopia or other visual disturbances; c. difficulty with speaking; d. difficulty with swallowing; e. the presence of nausea or vomiting; f. the presence of pain; g. feeling worried or anxious; h. presence of muscle strength at the biceps brachii muscle (Oxford Scale).
II. To compare the differences in PACU costs associated with use of each drug.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo standard of care surgery. Patients then receive neostigmine intravenously (IV) and glycopyrrolate IV at the completion of surgery.
GROUP II: Patients undergo standard of care surgery. Patients then receive sugammadex IV at the completion of surgery.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorGerman Echeverry
