Clinical trial · Interventional
Ketamine In Thoracic Surgery (KITS) Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.9% saline | Drug | — | UNRESOLVED |
| Ketamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ketamine
- description
- Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
- interventionNames
- Drug: Ketamine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 0.9 % saline bolus of equivalent volume
- interventionNames
- Drug: 0.9% saline
Primary outcomes (1)
- measure
- Interleukin Levels at 24 Hours
- timeFrame
- 24 Hours
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDRoytblat 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 9706914
- BACKGROUNDBartoc 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 16616662
- BACKGROUNDTashima 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 16754164
- BACKGROUNDCraig 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 11509263
- BACKGROUNDYim 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 10921716
- DERIVEDVekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20. PMID 39428602