Ketamine In Thoracic Surgery (KITS) Trial

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Ketamine

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.