NCT04162535

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

Contributions to the Elucidation of the Mechanisms and Effects by Which Certain Perianesthetic Interventions Modify Long-term Evolution of Patients With Digestive Cancers Subjected to Surgery

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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
BIOLOGICAL	Blood extraction	The patients will donate after consent 10 ml of blood prior and after surgery for further study
DRUG	Sevoflurane	Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent
DRUG	Propofol	Patients will receive a general anesthesia with Propofol as anesthetic agent

Timeline

• Start date: 2018-11-26
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-11-14
• Last updated: 2021-02-10

Locations

1 site across 1 country: Romania