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NCT01690988 · ClinicalTrials.gov registry record · Phase 3
The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial
A Phase 3 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 746
- Enrollment target
NCT01690988: Completed Phase 3 study, sponsored by Washington University School of Medicine.
NCT01690988 is a Phase 3 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 746 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01690988, a Phase 3 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 746 participants
- Enrollment target
Study Summary
Delirium is a medical term or condition that includes a temporary inability to focus attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than 60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug called ketamine can decrease the chance that patients will experience delirium after their surgery. The investigators are also testing whether ketamine decreases postoperative pain, postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital length of stay, and adverse outcomes (e.g. hallucinations and nightmares).
Primary Outcome
According to Confusion Assessment Method or Confusion Assessment Method for Intensive Care Unit criteria the number of patients that had any positive CAM on any day for all patients. The main effect evaluated will be to determine whether ketamine decreases delirium, table 3 of the protocol provides a useful guide for the potential findings of the current study with their implications. To further clarify, delirium will be assessed on the day of surgery, when possible and on the subsequent three
Interventions
- DRUG Ketamine (0.5 mg/kg)
- DRUG Normal Saline (placebo)
- DRUG Ketamine (1 mg/kg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 746 participants |
| Start Date | 2014-02-01 |
| Est. Completion | 2017-07 |
| Phase | Phase 3 |
What the finished NCT01690988 record still lists
NCT01690988 is an interventional study that assigns participants to a tested intervention. The registered 746 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Ketamine (0.5 mg/kg) is the first listed.
NCT01690988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01690988 about?
NCT01690988 is a clinical study titled "The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial". Delirium is a medical term or condition that includes a temporary inability to focus attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than 60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug called ketamine can decrease...
What is the current status of trial NCT01690988?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 746 participants. The study started on 2014-02-01. Estimated completion is 2017-07.
What interventions are being tested in trial NCT01690988?
The interventions under investigation include: Ketamine (0.5 mg/kg) (DRUG), Normal Saline (placebo) (DRUG), Ketamine (1 mg/kg) (DRUG).
Who is sponsoring clinical trial NCT01690988?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01690988's enrollment target sits among peer trials
746 474th of 2000 higher than 1,526 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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