MedTrace Logo

Ketamine In Thoracic Surgery (KITS) Trial

NCT00504725 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-07-25

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Ketamine

Interventional

DRUG

0.9% saline

placebo

Sponsors & Collaborators

Principal Investigators

  • Andy Shaw, M. D. · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00504725 on ClinicalTrials.gov