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
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