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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
450
Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively
Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
Clinica ATI, str Croitorilor nr 19-21
Cluj-Napoca, Cluj, Romania
RECRUITINGInstitutul Oncologic Prof Dr Ion Chiricuta
Cluj-Napoca, Cluj, Romania
RECRUITINGSurvival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer
Survival at 5 years will be recorded
Time frame: 5 years
Incidence of recurrences:
The incidence of recurrences will be registered annually and reported from the first year to 5 years respectively in all 4 groups of patients.
Time frame: 5 years
Morphine consumption during the first 24 postoperative hours
Total morphine consumption during the first 24h after surgery will be recorded
Time frame: 0- 24 h
Severity of postoperative pain - verbal response pain (VRPS) score 1-10, (1=no pain, 10=worst pain) in recovery room and during the first 48 hrs postoperatively. Target verbal response pain score ≤3
The severity of postoperative pain will be recorded along with morphine consumption.Pain intensity will be followed during the first 48 h postoperatively.
Time frame: 0- 48 h
Resumption of bowel function
Time to first flatus will be registered and compared between groups.
Time frame: 0-72 h
Length of hospital stay
LOS will be registered and compared between study groups.
Time frame: 0-10 days
Postoperative chronic pain
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
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Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively
Time frame: 1 year
Postoperative imflamation
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.
Time frame: Day 1
Rate of postoperative complications after intravenous lidocaine infusion versus placebo
Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia
Time frame: 0-30 days
Rate of postoperative complications after TIVA versus inhalation anaesthesia
Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia
Time frame: 0-30 days