Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Arrhythmia Agents

Channel Blockers

Platelet Aggregation Inhibitors

Fentanyl

Anesthetics

Lidocaine

Propofol

Sevoflurane

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Anesthetics, Inhalation

Anesthetics, General

TIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion.

Interventions: TIVA+lidocaine

TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion)

Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo).

Intervention: sevoflurane anesthesia +placebo (saline infusion)

Sevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively.

Intervention: sevoflurane anesthesia+ lidocaine infusion

Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively

TIVA+lidocaine

Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.

Sevoflurane+lidocaine

Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively

TIVA+placebo

Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively

Sevoflurane+placebo

Daniela IONESCU, Prof

Alexandru Alexa, Assist Prof

Daniela Ionescu, Prof

Alexa Alexandru, Assit Prof

Tiberiu Tat, PhD student

Alexandru Alexa, PhD student

Tiberiu Tat, doctor

Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without lidocaine on postoperative short and long term outcome in patients with colorectal cancer undergoing surgery.

As short term endpoints postoperative pain and opioid consumption, resumption of bowel function, PONV, LOS will be registered.

Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer recurrences incidence and mortality.

Main goals

1. Comparative evaluation of the incidence of recurrences after TIVA vs sevoflurane anesthesia
2. Evaluation of the effect of lidocaine infusion associated with TIVA/sevoflurane on the incidence of chronic pain and of cancer recurrences and survival.

Secondary objectives

1. Evaluation of the influence of lidocaine on postoperative outcome in patients with colorectal cancer
2. Evaluation of the influence of lidocaine on postoperative inflammatory response
3. Evaluation of the influence of lidocaine on the incidence and severity of postoperative pain and outcome in patients with colorectal cancer

Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

The Influence of Anesthesia on Postoperative Outcome and Complications in Colorectal Cancer Patients

An investigator will note any signs of local anaesthetics systemic toxicity at the bed site of patient

The incidence of recurrences will be registered annually and reported from the first year to 5 years respectively in all 4 groups of patients.

Total morphine consumption during the first 24h after surgery will be recorded

The severity of postoperative pain will be recorded along with morphine consumption.Pain intensity will be followed during the first 48 h postoperatively.

Time to first flatus will be registered and compared between groups.

LOS will be registered and compared between study groups.

Chronic pain at 6 month and 1 year respectively will be assessed with McGill questionnaire by telephone interview.

Scores range from 0 (no pain) to 78 (severe pain), patients with high scores need to seek medical advice

Evaluation of the influence of lidocaine on 24-hour postoperative inflammatory response; All patients will have leukocytes count and c protein reactive (PCR) so an analysis can be made.

Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Anesthesia and Postoperative Outcome in Colorectal Cancer Patients	NCT02786329	Colorectal Canc...	TIVA+lidocaine Sevoflurane+lid... TIVA+placebo Sevoflurane+pla...	18 Years - 80 Years	Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Anesthesia and Postoperative Outcome in Colorectal Cancer Patients	NCT02786329	Colorectal Canc...	TIVA+lidocaine Sevoflurane+lid... TIVA+placebo Sevoflurane+pla...	18 Years - 80 Years	Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Spots Global Cancer Trial Database for tiva+placebo

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