Evaluation of Sugammadex Vs. Neostigmine in the PACU for Abdominal Surgeries

Primary Objective:

• To evaluate the Length of Stay (LOS) in the PACU after a neuromuscular reversal with Sugammadex in comparison with Neostigmine/Glycopyrrolate in abdominal surgeries (hernia, gallbladder, etc.).
• Primary Endpoints: Date, Gender, Date of Procedure, Length of Procedure, Attending Anesthesiologist, Length of PACU stay (Admission and Discharge), Pain VAS score, Aldrete Score, Finger Saturation, and BP upon PACU discharge.

Study Design This is a prospective, randomized, study to evaluate the length of stay in the PACU after a neuromuscular reversal with Sugammadex in comparison with Neostigmine/Glycopyrrolate in abdominal surgeries (hernia, gallbladder surgeries, etc.) Inclusion Criteria

• 18-75 years of age
• Patients with surgeries with duration of 90-120 minutes
• ASA Patients I-III (Appendix A)
• Patients admitted to TGH for abdominal hernia repair, cholecystectomy and/or abdominal surgery as performed by Dr. Albrink
• BMI > 30 Exclusion Criteria
• <18 years of age
• ASA Patients IV and above (Appendix A)
• Patients with allergic reactions to Neostigmine+Glycopyrrolate and/or Sugammadex Patient Safety The patients enrolled in this study protocol are all in need of a general anesthetic supplemented by muscle relaxation, and able to receive rocuronium or vecuronium, the two most frequently used muscle relaxant at TGH. Both types of muscle relaxant can be reversed appropriately at the end of the surgical procedure with Bridion (sugammadex) or neostigmine in combination with Glycopyrrolate. The dose of the both reversal agents will be chosen to be equivalent for the intermediate level of neuromuscular blockade reached at the end of the surgical procedure. We have multiple year experience in using these two reversal drugs. Despite a difference in speed of onset, both drugs are commonly used in our operating room after these abdominal procedures. The reversal drugs are administered in the operating room toward the end of the procedure, when muscle paralysis of the abdominal wall is not required by the surgeon, and the anesthesiologist needs to awaken the patient and restore spontaneous ventilation. Side effects of both reversal agents might comprise especially bradycardia, usually reversed with Glyco supplementation, Other side effects and rarely allergy to the drug have been described and we are monitpring patients to maintain high safety throughout this period. The important notion is that the patient will be adequately reversed, breathing spontaneously, extubated and responding to appropriate questions before transfer to the PACU.

Methodology Consent Process All patients who are having abdominal surgeries at Tampa General Hospital (TGH) will be evaluated for study eligibility in the preoperative assessment center at TGH during their visit with the anesthesiologist. The pre-operative assessment takes place 3-7 days prior to the scheduled surgery. Patients who qualify for the study will be entered into the study during their pre-operative visit or the patient may take the consent form home to review and sign on the day of surgery. All study discussions will take place in a private exam room in the preoperative clinic. All subjects will be given the opportunity to ask questions. If the investigator feels that the subject understands the research parameters and the subject is willing to sign the consent form, the patient will be enrolled in the study. On the day of the surgical procedure, the study subject will present to the surgical prep unit. It is here that the subject will be re-evaluated for willingness to participate. Any additional questions will be answered prior to surgery.