Ketamine In Thoracic Surgery (KITS) Trial (KITS)

July 18, 2014 updated by: Duke University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed to be a phase 2 (efficacy) randomized controlled clinical trial of ketamine versus placebo in 40 patients undergoing lobectomy by VATS or open approach, at Duke University. We selected a single dose regimen of 0.5mg/kg IV ketamine given at induction of anesthesia, as this is the dose that previously has been shown to induce maximal suppression of the IL-6 response in cardiac 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. 40 patients (n=20 per group) will provide 90% power to detect a change in IL 6 of 20 pg/ml from a mean of 100 pg/ml at 4 hours, with two tailed alpha = 0.05. Allowing for 10-20% attrition we will enroll 50 patients to achieve this sample size. All patients presenting for lobectomy either VATS or open will be included. Patients will be screened by review of the preoperative surgical schedule posted each day and approached for consent to participate if they do not have any exclusion criteria. Patients who are randomized but do not undergo lobectomy for any reason will not be included in the analysis of the primary endpoint. Patients who are listed for VATS resection but convert to open will be included in the analysis on a per protocol basis. The randomization is stratified according to planned approach (VATS vs open), however we expect the majority of these cases to be VATS lobectomies.

Treatment will be by intravenous administration of a single dose of study drug over 5 minutes immediately after induction of anesthesia and before surgical incision.

Patients will be randomized (by sealed envelope) in blocks of 4 to receive ketamine or placebo. The randomization will be stratified according to whether the planned surgery is via VATS or open (thoracotomy) approach. The study drug will be prepared by the investigational pharmacy and provided to the attending anesthesiologist of record for the case. It will contain 0.5 mg/kg ketamine for injection by IV bolus over 5 minutes, or as an equivalent volume of 0.9% saline. It will be the responsibility of the principal investigator to ensure that study drug is administered in a timely fashion, usually by delegation to the attending anesthesiologist of record for the case. The anesthetic procedure will be standardized in that each patient will receive a total intravenous anesthetic using propofol and an intravenous opioid infusion. This anesthetic will be supplemented by an epidural and intravenous opioid boluses as needed to control pain.

Visits by the research team will be performed as follows:

  1. Visit 1 will occur at enrollment, when baseline information (see CRF visit 1) will be collected and study consent forms signed.
  2. Visit 2 will occur at induction of anesthesia when study drug will be administered and a baseline blood sample of 10ml collected from the patient's arterial line. The blood sample will be immediately centrifuged and the serum frozen and stored for subsequent analysis.
  3. Visit 3 will occur at 4 hours after completion of surgery when 10 ml blood will be collected and CRF visit 3 form will be completed (VAS score and emergence delirium).
  4. Visit 4 will occur at 24 hours after completion of surgery when 10 ml blood will be collected and CRF visit 4 form will be completed (VAS score).
  5. The final visit will occur just prior to hospital discharge when CRF visit 5 form will be completed (secondary endpoints). Additionally, if the principal investigator is informed by either study staff or the clinical team of an adverse event or other complication, then the patient will be visited within 24 hours for confirmation of the event and ascertainment of whether the event is related to study drug or not. An SAE form will be completed and sent to the IRB in line with institutional policy.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
Drug: Ketamine
Interventional
Placebo Comparator: Placebo
0.9 % saline bolus of equivalent volume
Drug: 0.9% saline
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Interleukin Levels at 24 Hours
Time Frame: 24 Hours
24 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive Protein (CRP) Serum Levels
Time Frame: 24 hours
The CRP levels were measured 24 hours postoperatively.
24 hours
Verbal Pain Scores
Time Frame: baseline, 4 hours, 24 hours and at discharge
Pain scores rated by the subject on a scale of 0 low - 10 high
baseline, 4 hours, 24 hours and at discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Andy Shaw, M. D., Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

July 18, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Estimate)

July 25, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00000895

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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