The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications in Patients 70 Years or Older and Scheduled for 3 Hour or Longer Surgery-A Randomized Controlled Trial

This study is designed to be an assessor-blinded, randomized, controlled, single center, parallel design trial at Oregon Health and Science University (OHSU) in Portland, Oregon. The investigators will enroll patients ≥ 70 years of age that are mentally competent to consent for anesthesia with a scheduled surgical length of ≥ 180 minutes on Monday through Friday in the South Operating Room Theatre at Oregon Health and Science University.

Subjects will be screened for inclusion in the study on either the day prior or the day of surgery. The initial review will occur by a quick view of the surgical posting sheet for the South Operating Rooms. Subjects undergoing any type of surgery will be eligible as long as neuromuscular paralysis is a component of the planned anesthetic. If subjects initially seem appropriate for inclusion, a more in depth chart review will occur. The research coordinator will approach patients that meet inclusion criteria in the Pre-operative Care Unit. Initially all patients 70 years of age or older will have equal probability of being approached for the study. At the halfway point of the study the investigators will monitor enrollment, and if ahead of schedule, preferentially select older patients in the 2nd half of the study-a group that is more likely to have Postoperative Pulmonary Complications (PPCs).

All subjects that are approached for recruitment will hear a description of the study, reasons for pursuing this research question, options for opting out the research protocol or not completing data collection, and potential risks, advantages, and disadvantages from participating. Subjects that agree to participate in the study will be asked to sign a written informed consent that has been approved by our Institutional Review Board. All subjects that agree to participate in the research study will be given a form describing the research study and providing contact information for the principal investigators. The subject's status in the research project will show up clearly on our medical records in their problem list, until the subject's time of participation is complete. A progress note will be placed in the subject's chart to allow other providers to easily contact study investigators. In addition, an electronic copy of the signed consent will be scanned into the medical records system and a copy of the signed consent will be made available for the subject to take home.

All subjects enrolled will have the following characteristics recorded by the research coordinator: age, sex, weight, body mass index, American Society of Anesthesiologists physical status classification score, creatinine clearance, and Charlson comorbidity index.

Subjects will be allocated to either neuromuscular reversal with sugammadex or neostigmine. Before study activation a sample of 200 sequentially numbered opaque envelopes will be prepared by an investigator not involved in patient recruitment, allocation, consent, or assessment: 100 for the sugammadex arm and 100 for the neostigmine arm. Patient allocation will occur in the operating room when the anesthesia provider notifies the coordinator that reversal is appropriate. At that time the research coordinator will open the lowest remaining numbered free envelope. Group assignment will be determined by a computer generated random number sequence produced in Excel (Redmond, Washington). The random number sequence will be generated by an investigator not involved in either patient enrollment or patient assignment. Reversal of rocuronium neuromuscular blockade (i.e. sugammadex or neostigmine) will be defined in the opened opaque envelope. Once a study subject signs a consent form, a unique number corresponding to the opened opaque envelope will be assigned to that subject. The envelope will not be opened until the anesthesia provider is ready to prepare and administer reversal of neuromuscular blockade. This subject number will never be reused and will remain with the subject for the entirety of the study. No subject will ever be allowed to have more than one unique subject number.