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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 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.

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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

FieldValue
Enrollment Target 40 participants
Start Date 2007-07
Est. Completion 2007-12
Phase Phase 2

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT00504725

The ClinicalTrials.gov registry entry for NCT00504725 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.