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

NCT ID: NCT04162535

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-26
• Study Completion Date: 2023-12-31

Brief Summary

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Sevoflurane

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

Group Type: EXPERIMENTAL

Blood extraction

Intervention Type: BIOLOGICAL

The patients will donate after consent 10 ml of blood prior and after surgery for further study

Sevoflurane

Intervention Type: DRUG

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

Total intravenous anesthesia

Patients will receive a general anesthesia with Propofol as anesthetic agent

Group Type: EXPERIMENTAL

Blood extraction

Intervention Type: BIOLOGICAL

The patients will donate after consent 10 ml of blood prior and after surgery for further study

Propofol

Intervention Type: DRUG

Patients will receive a general anesthesia with Propofol as anesthetic agent

Total intravenous anesthesia and Lidocaine

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

Group Type: EXPERIMENTAL

Lidocaine 1% Injectable Solution

Intervention Type: DRUG

Lidocaine 1% Injectable Solution Intervention Protocol for the TIVA and Lidocaine Arm

• Induction: 1.5 mg / kg i.v. bolus before induction (at the vein catch).
• Maintaining anesthesia: continuous infusion with Lidocaine 2 mg / kg / h, up to a maximum of 200 mg / h during maintenance (after IOT until waking)
• Infusion with 1% Lidocaine will be reduced to 1.0- 1.5 mg / kg / hour, max 100 mg / hour, for the first 48 hours postop

Blood extraction

Intervention Type: BIOLOGICAL

The patients will donate after consent 10 ml of blood prior and after surgery for further study

Placebo

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lidocaine 1% Injectable Solution

Lidocaine 1% Injectable Solution Intervention Protocol for the TIVA and Lidocaine Arm

• Induction: 1.5 mg / kg i.v. bolus before induction (at the vein catch).
• Maintaining anesthesia: continuous infusion with Lidocaine 2 mg / kg / h, up to a maximum of 200 mg / h during maintenance (after IOT until waking)
• Infusion with 1% Lidocaine will be reduced to 1.0- 1.5 mg / kg / hour, max 100 mg / hour, for the first 48 hours postop

Intervention Type: DRUG

Blood extraction

The patients will donate after consent 10 ml of blood prior and after surgery for further study

Intervention Type: BIOLOGICAL

Sevoflurane

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

Intervention Type: DRUG

Propofol

Patients will receive a general anesthesia with Propofol as anesthetic agent

Intervention Type: DRUG

Other Intervention Names

Antiarrythmic drug; Biologic Human Blood; Volatile Anesthetic Drug; Intravenous Anesthetic Drug

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

OTHER

Sponsor Role: collaborator

Prof. Dr. I. Chiricuta Institute of Oncology

OTHER

Sponsor Role: collaborator

Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Alexandru Alexa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ionescu Daniela, MD PHD DEEA

Role: STUDY_DIRECTOR

UMF Iuliu Hatieganu Cluj-Napoca

Locations

Institutu Regional de Gastroenterologie si Hepatologi Prof. Dr. O. Fodor

Cluj-Napoca, Cluj, Romania

Site Status: RECRUITING

Countries

Romania

Central Contacts

Alexandru Alexa, MD

Role: CONTACT

alexandru_reziati@yahoo.com

+40752691911

Ionescu Daniela, MD PHD

Role: CONTACT

dionescuati@yahoo.com

0744771209

Facility Contacts

Alexandru Alexa

Role: primary

alexandru_reziati@yahoo.com

+40752691911

Other Identifiers

418/14.11.2018

Identifier Type: -

Identifier Source: org_study_id