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Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

NCT02786329 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2022-01-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Prof. Dr. I. Chiricuta Institute of Oncology

    collaborator OTHER

  • Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

    lead OTHER

Principal Investigators

  • Daniela Ionescu, Prof · Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca

  • Alexandru Alexa, Assist Prof · Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2022-08-31
Completion
2022-12-31

Countries

  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02786329 on ClinicalTrials.gov