At a glance
ClinicalIndex Comparison Record- ✓Age 18-80 years
- ✓Undergoing non-emergent thoracic surgery
- ✓ASA physical status classification 2 to 4
- ✓No personal history of neuromuscular disease
- ✕Age <18 or >80 years
- ✕Does not speak English or Spanish
- ✕Planned postoperative intubation or ICU admission
- ✕Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Sugammadex Versus Neostigmine for Reversal of Rocuronium-induced Neuromuscular Blockade: A Study of Thoracic Surgical Patients
In Brief
A Phase 4 clinical trial evaluating Sugammadex and Neostigmine w/ Glycopyrrolate for Neuromuscular Blockade. Completed, enrolled 92 participants across 1 site.
Detailed Summary
This prospective, randomized, double blinded study is intended to enroll a total of 92 patients undergoing thoracic surgery with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either neostigmine or sugammadex for reversal of neuromuscular blockade. Merck, Inc. will supply the sugammadex through an agreement with Parkland Investigational Drug Services. Neostigmine is readily available for anesthesiologists to use and is the current standard of care for reversal of neuromuscular blockade. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. The surgeon, anesthesia team, postoperative recovery nurse, and research assistant will be blinded as to which reversal drug the patient receives. The only individual that will know to which drug the patient has been randomized will be the pharmacist who draws up the medication(s). A blinded research assistant will record postoperative outcomes and the patient will be followed 90 minutes postoperatively for any adverse events.
Study Details
Timeline
Interventions
Sugammadex 2 mg/kg
Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg