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Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT02786329
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Prof. Dr. I. Chiricuta Institute of Oncology
Information provided by (Responsible Party):
Prof.Dr.Daniela Ionescu, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Brief 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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: TIVA+lidocaine Drug: Sevoflurane+lidocaine Drug: TIVA+placebo Drug: Sevoflurane+placebo Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Influence of Anesthesia on Postoperative Outcome and Complications in Colorectal Cancer Patients
Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TIVA + lidocaine

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

Interventions: TIVA+lidocaine

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 Name: TIVA-L

Placebo Comparator: TIVA+placebo
TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion)
Drug: TIVA+placebo
Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
Other Name: TIVA-P

Placebo Comparator: Sevoflurane+placebo

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

Intervention: sevoflurane anesthesia +placebo (saline infusion)

Drug: Sevoflurane+placebo
Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively
Other Name: Sevo-P

Active Comparator: Sevoflurane+lidocaine

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

Intervention: sevoflurane anesthesia+ lidocaine infusion

Drug: Sevoflurane+lidocaine
Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
Other Name: Sevo-L




Primary Outcome Measures :
  1. Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer [ Time Frame: 5 years ]
  2. Incidence of recurrences: [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Morphine consumption during the first 24 postoperative hours [ Time Frame: 0- 24 h ]
  2. Severity of postoperative pain - verbal response pain (VRPS) score in recovery room and during the first 48 hrs postoperatively [ Time Frame: 0- 48 h ]
  3. Resumption of bowel function [ Time Frame: 0-72 h ]
  4. Length of hospital stay [ Time Frame: 0-10 days ]
  5. Postoperative chronic pain [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786329


Contacts
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Contact: Daniela IONESCU, Prof +40744771209 dionescuati@yahoo.com
Contact: Caius Breazu, Assist Prof +40743010012 csbreazu@yahoo.com

Locations
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Romania
Clinica ATI, str Croitorilor nr 19-21 Recruiting
Cluj-napoca, Cluj, Romania, 400162
Contact: Daniela Ionescu, Prof    +40744771209    dionescuati@yahoo.com   
Contact: Caius Breazu, Assit Prof    +40743010012    csbreazu@yahoo.com   
Principal Investigator: Tiberiu Tat, PhD student         
Institutul Oncologic Prof Dr Ion Chiricuta Recruiting
Cluj-Napoca, Cluj, Romania
Contact: Tiberiu Tat, doctor       dr_tibi@yahoo.com   
Sponsors and Collaborators
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Prof. Dr. I. Chiricuta Institute of Oncology
Investigators
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Principal Investigator: Daniela Ionescu, Prof Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca

Publications of Results:
Other Publications:
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Responsible Party: Prof.Dr.Daniela Ionescu, Professor, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
ClinicalTrials.gov Identifier: NCT02786329     History of Changes
Other Study ID Numbers: 53/14.03.2016
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Regular meeting for sharing data.

Keywords provided by Prof.Dr.Daniela Ionescu, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor:
colorectal cancer
TIVA
sevoflurane
lidocaine

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Anesthetics
Lidocaine
Propofol
Fentanyl
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid