Elucidation of the Mechanisms and Effects of Certain Anesthetic Interventions on Digestive Cancer Patients Subjected to Surgery

Iuliu Hatieganu University of Medicine and Pharmacy

Status and phase: Unknown; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: Sevoflurane; Drug: Lidocaine 1% Injectable Solution; Drug: Propofol; Biological: Blood extraction

Study type: Interventional

Funder types: Other

Identifiers

NCT04162535

418/14.11.2018

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 80 years old patients admitted for elective colorectal surgery

Exclusion criteria

• Pre-existing chronic pain
• Chronic medication that may interfere with pain: antiepileptics, NSAIDs, corticosteroids
• Contraindications to any of the medications in the study
• Significant psychiatric disorders (Axis I disorder) (major depressive disorders, bipolar disorders, schizophrenia, etc.)
• Hepatic (ALT and / or AST> 2 normal wave) or renal (serum creatinine> 2 mg / dl)
• Convulsive conditions that require medication in the last 2 years
• Planned regional analgesia and / or anesthesia (spinal or epidural)
• Corticosteroid-dependent asthma
• Autoimmune disorders
• Antiarrhythmic drugs (verapamil, propafenone, amiodarone) that may interfere with the antiarrhythmic action of lidocaine

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Sevoflurane

Experimental group

Description:

Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent

Treatment:

Biological: Blood extraction

Drug: Sevoflurane

Total intravenous anesthesia

Experimental group

Description:

Patients will receive a general anesthesia with Propofol as anesthetic agent

Treatment:

Biological: Blood extraction

Drug: Propofol

Total intravenous anesthesia and Lidocaine

Experimental group

Description:

Patients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol

Treatment:

Biological: Blood extraction

Drug: Lidocaine 1% Injectable Solution

Placebo

No Intervention group

Description:

10 presumed healthy volunteers that have donated 10 ml of venous blood for serum comparison