Sugammadex Versus Neostigmine for Reversal of Rocuronium-induced Neuromuscular Blockade: A Study of Thoracic Surgical Patients

Screening and Informed Consent:

A member of the research team will use a screening form to look for surgical patients that meet all of the inclusion and exclusion criteria. He/she will approach potential subjects during pre-anesthesia evaluation clinic (PAEC). Patients who are unable to be consented in PAEC will be approached in the preoperative area and the study will be explained in detail in a private room. Patients will be informed that they will receive no compensation for participating in the study and there will be no adverse consequences if they choose not to participate. If the subjects agree to participate, informed written consent will be obtained prior to any study procedures and this document will be sent to pmhresearchparticipants@phhs.org, for inclusion in the patient's medical record, per Parkland regulations. The study duration is from the start of anesthesia to 90 minutes postoperatively.

Anesthesia Protocol:

The anesthesia team that will be caring for the subject during surgery will be given the protocol for the study, which standardizes the general anesthetic technique. All patients will receive 0.6 mg/kg of rocuronium for neuromuscular paralysis during induction. Additional rocuronium will be given in 0.15 mg/kg increments to keep the patient at a neuromuscular depth of 1 twitch throughout the surgery. All patients will have the depth of neuromuscular block monitored at the non-dominant ulnar nerve at 60 mA with a TOF Watch accelerometer device, which provides real time feedback of the strength of contraction and graphically displays the relevant ratios.

Maintenance of anesthesia will be with sevoflurane in 70% oxygen, titrated to keep the bispectral index (BIS) between 40-60. All patients will have a forced air warming device (e.g., Bair Hugger, 3M, Maplewood, MN) used to maintain normothermia throughout the surgery. Subjects will be randomized to receive blinded study drug: either neostigmine or sugammadex for reversal of neuromuscular blockade, which will be administered intravenously at the beginning of skin closure. The anesthesia team will be blinded. The blinded study drug (reversal agent(s)) will be prepared into a 10 mL syringe by a pharmacist in Investigational Drug Service (IDS) Pharmacy and labeled in a blinded fashion as "sugammadex or neostigmine/glycopyrrolate." Any volume of blinded study drug (reversal agent(s)) that is less than 10 mL will be supplemented with 0.9% normal saline solution, preservation-free so that all syringes contain a volume of 10 mL and appear identical in order to preserve blinding. Any patient with clinical signs of inadequate reversal or failure of recovery of neuromuscular function [TOFR < 0.2] at 20 min after reversal will receive a rescue dose of sugammadex. The remaining aspects of the anesthetic will be standardized and not differ from the standard of care and will be similar for all patients.