Anesthesia and Postoperative Outcome in Colorectal Cancer Patients
NCT ID: NCT02786329
Last Updated: 2022-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
450 participants
INTERVENTIONAL
2016-06-30
2022-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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TIVA + lidocaine
TIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion.
Interventions: TIVA+lidocaine
TIVA+lidocaine
Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively
TIVA+placebo
TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion)
TIVA+placebo
Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
Sevoflurane+placebo
Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo).
Intervention: sevoflurane anesthesia +placebo (saline infusion)
Sevoflurane+placebo
Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively
Sevoflurane+lidocaine
Sevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively.
Intervention: sevoflurane anesthesia+ lidocaine infusion
Sevoflurane+lidocaine
Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
Interventions
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TIVA+lidocaine
Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively
Sevoflurane+lidocaine
Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
TIVA+placebo
Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
Sevoflurane+placebo
Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Prof. Dr. I. Chiricuta Institute of Oncology
OTHER
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
OTHER
Responsible Party
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Prof.Dr.Daniela Ionescu
Professor
Principal Investigators
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Daniela Ionescu, Prof
Role: PRINCIPAL_INVESTIGATOR
Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca
Alexandru Alexa, Assist Prof
Role: PRINCIPAL_INVESTIGATOR
Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca
Locations
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Clinica ATI, str Croitorilor nr 19-21
Cluj-Napoca, Cluj, Romania
Institutul Oncologic Prof Dr Ion Chiricuta
Cluj-Napoca, Cluj, Romania
Countries
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Central Contacts
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Facility Contacts
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References
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Fodale V, D'Arrigo MG, Triolo S, Mondello S, La Torre D. Anesthetic techniques and cancer recurrence after surgery. ScientificWorldJournal. 2014 Feb 6;2014:328513. doi: 10.1155/2014/328513. eCollection 2014.
Heaney A, Buggy DJ. Can anaesthetic and analgesic techniques affect cancer recurrence or metastasis? Br J Anaesth. 2012 Dec;109 Suppl 1:i17-i28. doi: 10.1093/bja/aes421.
Mao L, Lin S, Lin J. The effects of anesthetics on tumor progression. Int J Physiol Pathophysiol Pharmacol. 2013;5(1):1-10. Epub 2013 Mar 8.
Cakmakkaya OS, Kolodzie K, Apfel CC, Pace NL. Anaesthetic techniques for risk of malignant tumour recurrence. Cochrane Database Syst Rev. 2014 Nov 7;2014(11):CD008877. doi: 10.1002/14651858.CD008877.pub2.
Cassinello F, Prieto I, del Olmo M, Rivas S, Strichartz GR. Cancer surgery: how may anesthesia influence outcome? J Clin Anesth. 2015 May;27(3):262-72. doi: 10.1016/j.jclinane.2015.02.007. Epub 2015 Mar 11.
Divatia JV, Ambulkar R. Anesthesia and cancer recurrence: What is the evidence? J Anaesthesiol Clin Pharmacol. 2014 Apr;30(2):147-50. doi: 10.4103/0970-9185.129990. No abstract available.
Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.
Alexa AL, Tat TF, Ionescu D. The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study. Trials. 2022 Mar 18;23(1):219. doi: 10.1186/s13063-022-06157-4.
Other Identifiers
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53/14.03.2016
Identifier Type: -
Identifier Source: org_study_id
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