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NCT03138967 · ClinicalTrials.gov registry record · Phase 4
Investigation of Sugammadex in Outpatient Urological Procedures
A Phase 4 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
NCT03138967: Completed Phase 4 study, sponsored by M.D. Anderson Cancer Center.
NCT03138967 is a Phase 4 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 54 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03138967, a Phase 4 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 54 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome is to determine if Sugammadex can improve muscle recovery time, measured by time from administration of neuromuscular blockade reversal to train-of-four ratio of 0.9 in outpatient bladder procedures. It was assessed in the intraoperative period measuring the time from administration of reversal agent to TOF of 0.9 in minutes.
Interventions
- DRUG Rocuronium
- DRUG Sugammadex
- DRUG Neostigmine
- DRUG Glycopyrrolate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2017-09-18 |
| Est. Completion | 2019-11-24 |
| Phase | Phase 4 |
What the finished NCT03138967 record still lists
NCT03138967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which Rocuronium is the first listed.
NCT03138967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03138967 about?
NCT03138967 is a clinical study titled "Investigation of Sugammadex in Outpatient Urological Procedures". 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 drug...
What is the current status of trial NCT03138967?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2017-09-18. Estimated completion is 2019-11-24.
What interventions are being tested in trial NCT03138967?
The interventions under investigation include: Rocuronium (DRUG), Sugammadex (DRUG), Neostigmine (DRUG), Glycopyrrolate (DRUG).
Who is sponsoring clinical trial NCT03138967?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03138967's enrollment target sits among peer trials
54 1223rd of 2000 higher than 772 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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