Neuromuscular Blockade on Shoulder Pain of Elderly

Completed · Phase 4

Conditions studied: Malignant Neoplasms of Digestive Organs, Malignant Neoplasms of Female Genital Organs, Malignant Neoplasms of Male Genital Organs, Malignant Neoplasms of Urinary Tract

In brief

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.

Key facts

Study ID

NCT03210376

Run by

M.D. Anderson Cancer Center

People needed

100

Starts

2017-11-17

Expected to finish

2020-10-22

Last updated by the study team

2020-11-25

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 65 years of age or older
• Patients having robotic prostatectomy
• Written informed consent

You may not qualify if…

• Patient with known hypersensitivity to Rocuronium, Sugammadex or its components
• Patients with severe renal insufficiency, defined and confirmed by an estimated creatinine clearance equal or lower than 30 mL/min, per institutional laboratory.
• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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