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NCT03861988 · ClinicalTrials.gov registry record · Phase 4
Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery
A Phase 4 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT03861988: Completed Phase 4 study, sponsored by Stanford University.
NCT03861988 is a Phase 4 study that has completed, run by Stanford University. The registered enrollment target is 45 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03861988, a Phase 4 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study Summary
This study evaluates whether ketamine, given as part of an anesthetic, improves depression symptoms in depressed patients undergoing non-cardiac surgery. Half of participants will receive a ketamine infusion during surgery, while the other half will receive a placebo (normal saline) during surgery.
Primary Outcome
The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where lower MADRS scores indicate lower levels of depressive symptoms. The assessment for this outcome will be taken once daily on days 1, 2 and 3 post procedure. A mixed model for repeated measures (MMRM) was used to analyze the difference in postoperative MADRS score between ketamine and placebo groups..
Interventions
- DRUG Ketamine
- DRUG Normal saline (placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-08-22 |
| Est. Completion | 2022-09-27 |
| Phase | Phase 4 |
What the finished NCT03861988 record still lists
NCT03861988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT03861988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03861988 about?
NCT03861988 is a clinical study titled "Intraoperative Ketamine Versus Saline in Depressed Patients Undergoing Anesthesia for Non-cardiac Surgery". This study evaluates whether ketamine, given as part of an anesthetic, improves depression symptoms in depressed patients undergoing non-cardiac surgery. Half of participants will receive a ketamine infusion during surgery, while the other half will receive a placebo (normal saline) during surgery.
What is the current status of trial NCT03861988?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2019-08-22. Estimated completion is 2022-09-27.
What interventions are being tested in trial NCT03861988?
The interventions under investigation include: Ketamine (DRUG), Normal saline (placebo) (DRUG).
Who is sponsoring clinical trial NCT03861988?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03861988's enrollment target sits among peer trials
45 1354th of 2000 higher than 638 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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