CompletedPhase 2ketamine

Ketamine In Thoracic Surgery (KITS) Trial

Sponsored by Duke University

NCT ID
NCT00504725
Target Enrollment
40 participants
Start Date
2007-07
Est. Completion
2007-12

About This Study

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

Lung Cancer

Interventions

  • Ketamine
  • 0.9% saline

Eligibility

Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* All patients presenting for lobectomy either VATS or open.

Exclusion Criteria:

* 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.

Study Locations (1)

Duke University Medical Center
Durham, North Carolina, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source