Ketamine In Thoracic Surgery (KITS) Trial

Completed · Phase 2 · Has a placebo group

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00504725

Run by

Duke University

People needed

40

Starts

2007-07-01

Expected to finish

2007-12-01

Last updated by the study team

2014-07-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients presenting for lobectomy either VATS or open.

You may not qualify if…

• Patients with myocardial infarction in the previous six months,
• Patients with a history of psychotic disorder,
• Patients with a history of chronic pain syndrome,
• Patients with documented previous allergy to ketamine.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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