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- Registre américain des essais cliniques
- Essai clinique NCT00504725
Ketamine In Thoracic Surgery (KITS) Trial (KITS)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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:
- Visit 1 will occur at enrollment, when baseline information (see CRF visit 1) will be collected and study consent forms signed.
- 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.
- 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).
- 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).
- 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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Ketamine
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
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Interventional
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Comparateur placebo: Placebo
0.9 % saline bolus of equivalent volume
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placebo
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Interleukin Levels at 24 Hours
Délai: 24 Hours
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24 Hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
C-reactive Protein (CRP) Serum Levels
Délai: 24 hours
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The CRP levels were measured 24 hours postoperatively.
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24 hours
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Verbal Pain Scores
Délai: baseline, 4 hours, 24 hours and at discharge
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Pain scores rated by the subject on a scale of 0 low - 10 high
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baseline, 4 hours, 24 hours and at discharge
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Andy Shaw, M. D., Duke University
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Analgésiques
- Agents du système sensoriel
- Anesthésiques, Dissociatif
- Anesthésiques intraveineux
- Anesthésiques, général
- Anesthésiques
- Antagonistes des acides aminés excitateurs
- Agents d'acides aminés excitateurs
- Kétamine
Autres numéros d'identification d'étude
- Pro00000895
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