Neuromuscular Blockade on Shoulder Pain of Elderly
Condition: Malignant Neoplasms of Digestive Organs; Malignant Neoplasms of Female Genital Organs; Malignant Neoplasms of Male Genital Organs; Malignant Neoplasms of Urinary Tract
MeSH terms: Neoplasms; Genital Neoplasms, Female; Genital Neoplasms, Male; Urologic Neoplasms; Shoulder Pain
Intervention: Deep Neuromuscular Blockade (NMB); Moderate Neuromuscular Blockade (NMB); Sugammadex; Neostigmine; Pain Assessment
Intervention description: Deep Neuromuscular Blockade (NMB) given during surgery.; Moderate Neuromuscular Blockade (NMB) given during surgery.; 4 mg/Kg, intravenously as a single bolus injection after surgery.; 70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute after surgery.; Pain assessment done at about 15, 45, and 90 minutes after surgery.
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Malignant neoplasms of digestive organs; Malignant neoplasms of female genital organs; Malignant neoplasms of male genital organs; Malignant neoplasms of urinary tract; Neuromuscular blockade; NMB; Sugammadex; Neostigmine; Pain Assessment; Survey

Summary:

      Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the
      abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a
      common complaint from patients who have had abdominal surgery and the pain is thought to be
      related to the use of IP.

      In addition to anesthesia (which keeps you asleep during surgery), the current standard
      practice is to block the nerve-muscle junction with a type of drug called neuromuscular
      blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of
      insufflation pressure is needed by the surgeon.

      To reverse the effects of NMB after surgery, a drug called neostigmine is given.

      The goal of this clinical research study is to compare the use of standard-of-care moderate
      NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly
      patients (patients who are 65 years of age or older) who are scheduled to have robotic
      abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the
      NMB given.

      This is an investigational study. Sugammadex and neostigmine are FDA approved and
      commercially available for the reversal of NMB. It is considered investigational to compare
      Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can
      reduce the level of shoulder pain after surgery.

      Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients 65 years of age or older

          2. Patients having robotic prostatectomy

          3. Written informed consent

        Exclusion Criteria:

          1. Patient with known hypersensitivity to Rocuronium, Sugammadex or its components

          2. Patients with severe renal insufficiency, defined and confirmed by an estimated
             creatinine clearance equal or lower than 30 mL/min, per institutional laboratory.

          3. Patients with history of severe liver disease, defined as and confirmed by elevated
             ALT and AST greater than 1.5 times the Upper Limit of Normal along with Albumin less
             than 3 OR INR 1.5 or greater per institutional laboratory.