NCT02786329

Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	TIVA+lidocaine	Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively
DRUG	Sevoflurane+lidocaine	Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
DRUG	TIVA+placebo	Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
DRUG	Sevoflurane+placebo	Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively

Timeline

• Start date: 2016-06-01
• Primary completion: 2022-08-01
• Completion: 2022-12-01
• First posted: 2016-06-01
• Last updated: 2022-01-20

Locations

2 sites across 1 country: Romania