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NCT04562597 · ClinicalTrials.gov registry record · Phase 1
A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.
A Phase 1 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT04562597: Completed Phase 1 study, sponsored by Medical University of South Carolina.
NCT04562597 is a Phase 1 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04562597, a Phase 1 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
Determine the optimal dose of IV N-acetylcysteine (NAC) to produce opioid reduction following spine surgery and estimate the difference in opioid consumption between placebo and the selected optimal dose.
Primary Outcome
Post operative opioid consumption in the 12 hours that occur post-operatively.
Interventions
- DRUG Dose Response Curve Placebo
- DRUG Dose Response Curve N-acetylcysteine 50 mg/kg
- DRUG Dose Response Curve N-acetylcysteine 100 mg/kg
- DRUG Dose Response Curve N-acetylcysteine 150 mg/kg
- DRUG Opioid Reduction with Optimal N-acetylcysteine Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-01-20 |
| Est. Completion | 2022-05-21 |
| Phase | Phase 1 |
What the finished NCT04562597 record still lists
NCT04562597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which Dose Response Curve Placebo is the first listed.
NCT04562597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04562597 about?
NCT04562597 is a clinical study titled "A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.". Determine the optimal dose of IV N-acetylcysteine (NAC) to produce opioid reduction following spine surgery and estimate the difference in opioid consumption between placebo and the selected optimal dose.
What is the current status of trial NCT04562597?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2021-01-20. Estimated completion is 2022-05-21.
What interventions are being tested in trial NCT04562597?
The interventions under investigation include: Dose Response Curve Placebo (DRUG), Dose Response Curve N-acetylcysteine 50 mg/kg (DRUG), Dose Response Curve N-acetylcysteine 100 mg/kg (DRUG), Dose Response Curve N-acetylcysteine 150 mg/kg (DRUG), Opioid Reduction with Optimal N-acetylcysteine Dose (DRUG).
Who is sponsoring clinical trial NCT04562597?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04562597's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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