Phase 2
Completed N=41
Ketamine In Thoracic Surgery (KITS) Trial
Source: ClinicalTrials.gov NCT00504725 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Interleukin Levels at 24 Hours — 245; 269; 11.3; 14.8 pg/ml — p=0.39
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Interleukin Levels at 24 Hours |
245; 269; 11.3; 14.8; 3.0; 4.9 | 0.39 |
| SECONDARY C-reactive Protein (CRP) Serum Levels |
8.8; 9.3 | 0.37 |
| SECONDARY Verbal Pain Scores |
0.30; 0.35; 3.8; 3.1; 2.6; 2.8 | 0.44 |
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.
Data sourced from ClinicalTrials.gov (NCT00504725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.