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| Name | Class |
|---|---|
| Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor | OTHER |
| Prof. Dr. I. Chiricuta Institute of Oncology | OTHER |
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Digestive cancers (liver, colonic, pancreatic) have a high incidence and high mortality, their population prevalence is also increasing. Given that the anesthesia techniques and the agents used act directly and indirectly on the immune system during the perioperative period, influencing both the treatment and the prognosis of patients with colorectal cancer who undergo elective interventions, a series of perianesthetic interventions have been proposed in order to reduce morbidity-mortality perioperative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane | Experimental | Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent |
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| Total intravenous anesthesia | Experimental | Patients will receive a general anesthesia with Propofol as anesthetic agent |
|
| Total intravenous anesthesia and Lidocaine | Experimental | Patients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol |
|
| Placebo | No Intervention | 10 presumed healthy volunteers that have donated 10 ml of venous blood for serum comparison |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 1% Injectable Solution | Drug | Lidocaine 1% Injectable Solution Intervention Protocol for the TIVA and Lidocaine Arm
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the antiproliferative and apoptotic effects of anesthetic agents | The investigators aim to correlate the anticancer effects of two anesthetic techniques with tumor markers (p53;p38) and cell proteins involved in proliferation or apoptosis (IGFR;Bcl-2;Bcl-6). The investigators will report if the anesthetic agent used in cancer surgery influences the serologic values of these markers. | up to 4 years |
| Evaluation of patients serum on cell culture | The investigators will investigate the serum of the patients who received different types of anesthesia (elective colorectal cancer surgery) by incubating it with colon cell lines (HCT116). The investigators will concentrate on cell proliferation assay. The investigators aim to discover how the growth of HCT116 will be influenced by patients' serum in terms of rate of proliferation. The measurements which will be used are Inhibitory Concentration (IC50) measured at 0 , 24 and 48 hours after incubation. The concentrations will be measured in mcg/ml. | up to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Lidocaine concentration | The investigators aim to determine de plasmatic concentration of lidocaine in the patients serum , which have received lidocaine perioperatively. The investigators will do a Mass-Spec analysis of lidocaine | up to 4 years |
| Survival Comparison |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandru Alexa, MD | Contact | +40752691911 | alexandru_reziati@yahoo.com | |
| Ionescu Daniela, MD PHD | Contact | 0744771209 | dionescuati@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ionescu Daniela, MD PHD DEEA | UMF Iuliu Hatieganu Cluj-Napoca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institutu Regional de Gastroenterologie si Hepatologi Prof. Dr. O. Fodor | Recruiting | Cluj-Napoca | Cluj | 400469 | Romania |
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| Blood extraction | Biological | The patients will donate after consent 10 ml of blood prior and after surgery for further study |
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| Sevoflurane | Drug | Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent |
|
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| Propofol | Drug | Patients will receive a general anesthesia with Propofol as anesthetic agent |
|
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The investigators will do a follow up for the patients in all the 3 groups. The investigators want to investigate the survival ratio for the patients that had a elective colorectal cancer surgery. |
| up to 5 years |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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