Phase 4
Completed N=54
Investigation of Sugammadex in Outpatient Urological Procedures
Malignant Neoplasms of Urinary Tract · Bladder Cancer
Source: ClinicalTrials.gov NCT03138967 ↗
Enrolled (actual)
54
Serious AEs
2.0%
Results posted
Jul 2019
Primary outcomePrimary: Muscle Recovery Time — 2; 9.24 minutes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Muscle Recovery Time |
2; 9.24 | — |
| SECONDARY PostOperative Complications |
5; 7 | — |
| SECONDARY Overall Recovery Time |
2.0847; 2.4727 | — |
Eligibility Criteria
Inclusion Criteria
- Is scheduled to undergo cystoscopy with bladder resection procedure under general anesthesia requiring neuromuscular relaxation using rocuronium bromide to secure airway and requiring neuromuscular reversal at The University of Texas MD Anderson Cancer Center - Mays Clinic (ACB-outpatient)
- Male or Females who are >= 18 years of age
- Classified by the American Society of Anesthesiologists (ASA) as Class I - IV
- Candidate for use of laryngeal mask airway (LMA)
- Able to give consent
Exclusion Criteria
- Severe renal impairment as measured eGFR less than 30 per institutional laboratory.
- Females who are pregnant or might be pregnant or are breast-feeding.
- Females who have been diagnosed with breast cancer and currently taking Toremifene
- Is known or suspected to have significant hepatic dysfunction, with AST & ALT 3 times above UNL per institutional laboratory.
- Is known or suspected to have a (family) history of malignant hyperthermia
- Is known or suspected to have an allergy to opioids, muscle relaxants or other medications used during general anesthesia
- Is known or suspected to have neuromuscular disorders (ex: myasthenia gravis)
Data sourced from ClinicalTrials.gov (NCT03138967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.