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NCT03210376 · ClinicalTrials.gov registry record · Phase 4
Neuromuscular Blockade on Shoulder Pain of Elderly
A Phase 4 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT03210376: Completed Phase 4 study, sponsored by M.D. Anderson Cancer Center.
NCT03210376 is a Phase 4 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03210376, a Phase 4 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Sugammadex
- DRUG Neostigmine
- BEHAVIORAL Pain Assessment
- DRUG Deep Neuromuscular Blockade (NMB)
- DRUG Moderate Neuromuscular Blockade (NMB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-11-17 |
| Est. Completion | 2020-10-22 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03210376
The ClinicalTrials.gov registry entry for NCT03210376 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Sugammadex is the first listed.
NCT03210376 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03210376 about?
NCT03210376 is a clinical study titled "Neuromuscular Blockade on Shoulder Pain of Elderly". 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. I...
What is the current status of trial NCT03210376?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2017-11-17. Estimated completion is 2020-10-22.
What interventions are being tested in trial NCT03210376?
The interventions under investigation include: Sugammadex (DRUG), Neostigmine (DRUG), Pain Assessment (BEHAVIORAL), Deep Neuromuscular Blockade (NMB) (DRUG), Moderate Neuromuscular Blockade (NMB) (DRUG).
Who is sponsoring clinical trial NCT03210376?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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