Investigation of Sugammadex in Outpatient Urological Procedures
Status:
Completed
Trial end date:
2019-11-24
Target enrollment:
Participant gender:
Summary
The goal of this clinical research study is to determine whether using sugammadex, given with
a standard muscle relaxation drug during bladder surgeries, improves anesthesia conditions
and recovery time.
During some bladder operations, your muscles must be completely relaxed. Muscle relaxation
drugs cause the muscles to relax, including the respiratory muscles, and as a result
artificial ventilation is needed to help you breathe. Sugammadex and other standard drugs
reverse the effect of the muscle relaxation drugs, allowing you to breathe on your own after
the operation.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 study groups. This is done because no one knows if one study group is better,
the same, or worse than the other group:
- If you are in Group 1, you will receive sugammadex to reverse the muscle relaxation.
- If you are in Group 2, you will receive the standard of care
(neostigmine/glycopyrrolate) to reverse the muscle relaxation.
You and the surgeon will not know which group you have been assigned to. However, the
anesthesiologist and study staff will know.
Length of Study:
You will be on study for up to 1 week after the cystoscopy. If you are unable to have the
procedure performed, you may be taken off study early.
This is an investigational study. Sugammadex and neostigmine/glycopyrrolate are all FDA
approved and commercially available to reverse muscle relaxation. The comparison of these
drugs is investigational.
Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.