NCT00504725

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
5 years until next milestone

Results Posted

Study results publicly available

November 16, 2012

Completed
Last Updated

July 25, 2014

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

July 18, 2007

Results QC Date

September 29, 2011

Last Update Submit

July 18, 2014

Conditions

Lung Cancer

Keywords

LobectomyVATS

Outcome Measures

Primary Outcomes (1)

  • Interleukin Levels at 24 Hours

    24 Hours

Secondary Outcomes (2)

  • C-reactive Protein (CRP) Serum Levels

    24 hours

  • Verbal Pain Scores

    baseline, 4 hours, 24 hours and at discharge

Study Arms (2)

Ketamine

EXPERIMENTAL

Single bolus 0.5mg/kg ketamine IV after induction of anesthesia

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

0.9 % saline bolus of equivalent volume

Drug: 0.9% saline

Interventions

KetamineDRUG

Interventional

Ketamine
0.9% salineDRUG

placebo

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients presenting for lobectomy either VATS or open.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

  • Roytblat L, Talmor D, Rachinsky M, Greemberg L, Pekar A, Appelbaum A, Gurman GM, Shapira Y, Duvdenani A. Ketamine attenuates the interleukin-6 response after cardiopulmonary bypass. Anesth Analg. 1998 Aug;87(2):266-71. doi: 10.1097/00000539-199808000-00006.

    PMID: 9706914BACKGROUND

  • Bartoc C, Frumento RJ, Jalbout M, Bennett-Guerrero E, Du E, Nishanian E. A randomized, double-blind, placebo-controlled study assessing the anti-inflammatory effects of ketamine in cardiac surgical patients. J Cardiothorac Vasc Anesth. 2006 Apr;20(2):217-22. doi: 10.1053/j.jvca.2005.12.005. Epub 2006 Mar 9.

    PMID: 16616662BACKGROUND

  • Tashima T, Yamashita J, Nakano S, Joutsuka T, Hayashi N, Saishoji T, Ogawa M. Comparison of video-assisted minithoracotomy and standard open thoracotomy for the treatment of non-small cell lung cancer. Minim Invasive Ther Allied Technol. 2005;14(3):203-8. doi: 10.1080/13645700510034001.

    PMID: 16754164BACKGROUND

  • Craig SR, Leaver HA, Yap PL, Pugh GC, Walker WS. Acute phase responses following minimal access and conventional thoracic surgery. Eur J Cardiothorac Surg. 2001 Sep;20(3):455-63. doi: 10.1016/s1010-7940(01)00841-7.

    PMID: 11509263BACKGROUND

  • Yim AP, Wan S, Lee TW, Arifi AA. VATS lobectomy reduces cytokine responses compared with conventional surgery. Ann Thorac Surg. 2000 Jul;70(1):243-7. doi: 10.1016/s0003-4975(00)01258-3.

    PMID: 10921716BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

KetamineSaline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Andrew Shaw MD
Organization
Duke University Medical Center
andrew.shaw@duke.edu
9192866938

Study Officials

  • Andy Shaw, M. D.

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2007

First Posted

July 20, 2007

Study Start

July 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 25, 2014

Results First Posted

November 16, 2012

Record last verified: 2012-11

Locations

US(1)