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NCT00504725 · ClinicalTrials.gov registry record · Phase 2
Ketamine In Thoracic Surgery (KITS) Trial
A Phase 2 study of Lung Cancer, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00504725: Completed Phase 2 study of Lung Cancer, sponsored by Duke University.
NCT00504725 is a Phase 2 study of Lung Cancer that has completed, run by Duke University. The registered enrollment target is 40 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00504725, a Phase 2 study of Lung Cancer, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aim of the study is to demonstrate a reduction in circulating interleukin 6 levels at 4 and 24 hours after completion of lobectomy (either VATS or open). The null hypothesis (H0) is thus that there is no difference in circulating interleukin 6 levels when patients are given either ketamine or placebo (0.9% saline in equivalent volume). The alternative (two tailed) hypothesis (HA) if the null is disproved is that ketamine leads to significantly different levels of interleukin 6 at 4 and 24 hours after completion of surgery. We plan to randomize 40 patients to receive either ketamine or placebo, in a block of 4 randomization design stratified by whether surgery is performed by VATS or open lobectomy.
Conditions Studied
Interventions
- DRUG Ketamine
- DRUG 0.9% saline
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-07 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
What the finished NCT00504725 record still lists
NCT00504725 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Ketamine is the first listed.
NCT00504725 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00504725 about?
NCT00504725 is a clinical study titled "Ketamine In Thoracic Surgery (KITS) Trial". The primary aim of the study is to demonstrate a reduction in circulating interleukin 6 levels at 4 and 24 hours after completion of lobectomy (either VATS or open). The null hypothesis (H0) is thus that there is no difference in circulating interleukin 6 levels when patients are given either ketami...
What is the current status of trial NCT00504725?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2007-07. Estimated completion is 2007-12.
What conditions does trial NCT00504725 study?
This clinical trial studies the following conditions: Lung Cancer.
What interventions are being tested in trial NCT00504725?
The interventions under investigation include: Ketamine (DRUG), 0.9% saline (DRUG).
Who is sponsoring clinical trial NCT00504725?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00504725 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00504725's enrollment target sits among peer trials
40 294th of 409 higher than 108 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer 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.
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