CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00504725
NCT00504725Phase 2Completed

Ketamine In Thoracic Surgery (KITS) Trial

Duke University·interventional·Posted Jul 20, 2007·Updated Jul 25, 2014

In Brief

A Phase 2 clinical trial evaluating Ketamine and 0.9% saline for Lung Cancer. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 20, 2007
Enrollment StartJul 1, 2007
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.9 years ago

Interventions

Ketaminedrug

Interventional

0.9% salinedrug

placebo