Trial | NCT02786329  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    450
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

Comparative evaluation of the incidence of recurrences after TIVA vs sevoflurane anesthesia
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

Evaluation of the influence of lidocaine on postoperative outcome in patients with colorectal cancer
Evaluation of the influence of lidocaine on postoperative inflammatory response
Evaluation of the influence of lidocaine on the incidence and severity of postoperative pain and outcome in patients with colorectal cancer
Study Started
Jun 30
2016
Primary Completion
Aug 31
2022
Anticipated
Study Completion
Dec 31
2022
Anticipated
Last Update
Jan 20
2022

Drug TIVA+lidocaine

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

  • Other names: TIVA-L

Drug Sevoflurane+lidocaine

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

  • Other names: Sevo-L

Drug TIVA+placebo

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

  • Other names: TIVA-P

Drug Sevoflurane+placebo

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

  • Other names: Sevo-P

TIVA + lidocaine Active Comparator

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

TIVA+placebo Placebo Comparator

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

Sevoflurane+placebo Placebo Comparator

Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo). Intervention: sevoflurane anesthesia +placebo (saline infusion)

Sevoflurane+lidocaine Active Comparator

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

Criteria 

Inclusion Criteria:

Elective surgery

Exclusion Criteria:

• persistent chronic pain

chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
Contraindications for any of the study medications
Significant psychiatric disorders (Axa I) (major depression, bipolar disorders, schizophrenia, etc.)
Significant hepatic (ALAT and/or ASAT > 2 normal values) or renal (plasma creatinine > 2 mg/dl) disorders
Convulsive disorders requiring medication during the last 2 years
Planned regional analgesia/anesthesia (spinal or epidural)
Corticoid dependent asthma
Autoimmune disorders
Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
Refusal for study participation
No Results Posted