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Neuromuscular Blockade on Shoulder Pain of Elderly

NCT03210376 · M.D. Anderson Cancer Center · Updated 25 Nov 2020

What is being tested
Deep Neuromuscular Blockade (NMB); Moderate Neuromuscular Blockade (NMB); Sugammadex; Neostigmine; Pain Assessment
For
Malignant Neoplasms of Digestive Organs; Malignant Neoplasms of Female Genital Organs; Malignant Neoplasms of Male Genital Organs; Malignant Neoplasms of Urinary Tract
Kind of study
Tests a treatment or device on volunteers. Phase 4.
Who can join
Ages 65 years and older. About 100 people. The full rules are on the registry page.
Where
United States
When
Starts or started 17 Nov 2017, ends 22 Oct 2020. Registered 6 July 2017.
Results
Posted on the registry on 7 Oct 2019.

In the researchers' words

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…
ClinicalTrials.gov, NCT03210376

Sites

  • University of Texas MD Anderson Cancer CenterHouston, Texas, United States